Levothyroxine Sodium Tablets USP 25mcg
Categories: , ,
Date:

Levothyroxine Sodium Tablets USP 25mcg Technical Specification:

Product Name: Levothyroxine Sodium Tablets USP 25mcg
Brand Name: Generic
Strength: (25mcg), (50mcg), (75mcg), (88mcg), (100mcg), (125mcg), (175mcg), (200mcg), (300mcg), (600mcg)
Dosage Form: Tablets (Uncoated)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Hypothyroidism
Indication: Levothyroxine is a medicine used to treat an underactive thyroid gland (hypothyroidism).
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from Light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Levothyroxine Sodium Tablets USP 25mcg
    Each uncoated tablet contains:
    L-Thyroxine Sodium USP
    Equivalent to anhydrous L-Thyroxine Sodium……….25mcg
    Excipients……………………………………………………………….q.s.
    Color: Ferric oxide yellow
  • Levothyroxine Sodium Tablets USP 50mcg
    Each uncoated tablet contains:
    L-Thyroxine Sodium USP
    Equivalent to anhydrous L-Thyroxine Sodium……….50mcg
    Excipients……………………………………………………………….q.s.
    Color: Lake of quinoline yellow FCF
  • Levothyroxine Sodium Tablets USP 75mcg
    Each uncoated tablet contains:
    L-Thyroxine Sodium USP
    Equivalent to anhydrous L-Thyroxine Sodium……….75mcg
    Excipients……………………………………………………………….q.s.
    Color: Ferric oxide black
  • Levothyroxine Sodium Tablets USP 88mcg
    Each uncoated tablet contains:
    L-Thyroxine Sodium USP
    Equivalent to anhydrous L-Thyroxine Sodium……….88mcg
    Excipients……………………………………………………………….q.s.
    Color: Lake tartrazine
  • Levothyroxine Sodium Tablets USP 100mcg
    Each uncoated tablet contains:
    L-Thyroxine Sodium USP
    Equivalent to anhydrous L-Thyroxine Sodium……….100mcg
    Excipients……………………………………………………………….q.s.
    Color: Lake of Erythrosine
  • Levothyroxine Sodium Tablets USP 125mcg
    Each uncoated tablet contains:
    L-Thyroxine Sodium USP
    Equivalent to anhydrous L-Thyroxine Sodium……….125mcg
    Excipients……………………………………………………………….q.s.
    Color: Tartrazine yellow
  • Levothyroxine Sodium Tablets USP 175mcg
    Each uncoated tablet contains:
    L-Thyroxine Sodium USP
    Equivalent to anhydrous L-Thyroxine Sodium……….175mcg
    Excipients……………………………………………………………….q.s.
    Color: Sunset yellow aluminium lake
  • Levothyroxine Sodium Tablets USP 200mcg
    Each uncoated tablet contains:
    L-Thyroxine Sodium USP
    Equivalent to anhydrous L-Thyroxine Sodium……….200mcg
    Excipients……………………………………………………………….q.s.
    Color: Quinoline yellow SS
  • Levothyroxine Sodium Tablets USP 300mcg
    Each uncoated tablet contains:
    L-Thyroxine Sodium USP
    Equivalent to anhydrous L-Thyroxine Sodium……….300mcg
    Excipients……………………………………………………………….q.s.
    Color: Ponceau 4 R
  • Levothyroxine Sodium Tablets USP 600mcg
    Each uncoated tablet contains:
    L-Thyroxine Sodium USP
    Equivalent to anhydrous L-Thyroxine Sodium……….600mcg
    Excipients……………………………………………………………….q.s.
    Color: Indigo carmine

THERAPEUTIC INDICATIONS:

Levothyroxine is a medicine used to treat an underactive thyroid gland (hypothyroidism). The thyroid gland makes thyroid hormones which help to control energy levels and growth. Levothyroxine is taken to replace the missing thyroid hormone thyroxine.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
Replace Cap Tightly After Use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage:  Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from Light and moisture.
Dispense in tight, light-resistant container as described in the USP.

Dosage: As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Levothyroxine Sodium Tablets USP 25mcg
B) Levothyroxine Sodium Tablets USP 50mcg
C) Levothyroxine Sodium Tablets USP 75mcg
D) Levothyroxine Sodium Tablets USP 88mcg
E) Levothyroxine Sodium Tablets USP 100mcg
F) Levothyroxine Sodium Tablets USP 125mcg
G) Levothyroxine Sodium Tablets USP 175mcg
H) Levothyroxine Sodium Tablets USP 200mcg
I) Levothyroxine Sodium Tablets USP 300mcg
J) Levothyroxine Sodium Tablets USP 600mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Levothyroxine Sodium Tablets USP 25mcg
Each uncoated tablet contains:
L-Thyroxine Sodium USP
Equivalent to anhydrous L-Thyroxine Sodium……….25mcg
Excipients……………………………………………………………….q.s.
Color: Ferric oxide yellow

B) Levothyroxine Sodium Tablets USP 50mcg
Each uncoated tablet contains:
L-Thyroxine Sodium USP
Equivalent to anhydrous L-Thyroxine Sodium……….50mcg
Excipients……………………………………………………………….q.s.
Color: Lake of quinoline yellow FCF

C) Levothyroxine Sodium Tablets USP 75mcg
Each uncoated tablet contains:
L-Thyroxine Sodium USP
Equivalent to anhydrous L-Thyroxine Sodium……….75mcg
Excipients……………………………………………………………….q.s.
Color: Ferric oxide black

D) Levothyroxine Sodium Tablets USP 88mcg
Each uncoated tablet contains:
L-Thyroxine Sodium USP
Equivalent to anhydrous L-Thyroxine Sodium……….88mcg
Excipients……………………………………………………………….q.s.
Color: Lake tartrazine

E) Levothyroxine Sodium Tablets USP 100mcg
Each uncoated tablet contains:
L-Thyroxine Sodium USP
Equivalent to anhydrous L-Thyroxine Sodium……….100mcg
Excipients……………………………………………………………….q.s.
Color: Lake of Erythrosine

F) Levothyroxine Sodium Tablets USP 125mcg
Each uncoated tablet contains:
L-Thyroxine Sodium USP
Equivalent to anhydrous L-Thyroxine Sodium……….125mcg
Excipients……………………………………………………………….q.s.
Color: Tartrazine yellow

G) Levothyroxine Sodium Tablets USP 175mcg
Each uncoated tablet contains:
L-Thyroxine Sodium USP
Equivalent to anhydrous L-Thyroxine Sodium……….175mcg
Excipients……………………………………………………………….q.s.
Color: Sunset yellow aluminum lake

H) Levothyroxine Sodium Tablets USP 200mcg
Each uncoated tablet contains:
L-Thyroxine Sodium USP
Equivalent to anhydrous L-Thyroxine Sodium……….200mcg
Excipients……………………………………………………………….q.s.
Color: Quinoline yellow SS

I) Levothyroxine Sodium Tablets USP 300mcg
Each uncoated tablet contains:
L-Thyroxine Sodium USP
Equivalent to anhydrous L-Thyroxine Sodium……….300mcg
Excipients……………………………………………………………….q.s.
Color: Ponceau 4 R

J) Levothyroxine Sodium Tablets USP 600mcg
Each uncoated tablet contains:
L-Thyroxine Sodium USP
Equivalent to anhydrous L-Thyroxine Sodium……….600mcg
Excipients……………………………………………………………….q.s.
Color: Indigo carmine

THERAPEUTIC INDICATIONS:

Levothyroxine is a medicine used to treat an underactive thyroid gland (hypothyroidism). The thyroid gland makes thyroid hormones which help to control energy levels and growth. Levothyroxine is taken to replace the missing thyroid hormone thyroxine.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
REPLACE CAP TIGHTLY AFTER USE.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.

WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from Light and moisture.
Dispense in tight, light-resistant container as described in the USP.

Dosage: As directed by the Physician.