lithium carbonate

Generic: lithium carbonate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lithium carbonate
Generic Name lithium carbonate
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

lithium carbonate 300 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0021
Product ID 0054-0021_5e0351f3-360d-4044-a40a-a36f0008cf92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076832
Listing Expiration 2026-12-31
Marketing Start 2004-10-28

Pharmacologic Class

Classes
mood stabilizer [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540021
Hyphenated Format 0054-0021

Supplemental Identifiers

RxCUI
197891
UNII
2BMD2GNA4V

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lithium carbonate (source: ndc)
Generic Name lithium carbonate (source: ndc)
Application Number ANDA076832 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0021-25)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0021-29)
source: ndc

Packages (2)

0054-0021-25 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0021-25) 0054-0021-29 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0021-29)

Ingredients (1)

lithium carbonate (300 mg/1)

Linked Drug Pages (1)

Lithium Carbonate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5e0351f3-360d-4044-a40a-a36f0008cf92", "openfda": {"unii": ["2BMD2GNA4V"], "rxcui": ["197891"], "spl_set_id": ["c612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0021-25)", "package_ndc": "0054-0021-25", "marketing_start_date": "20041028"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0021-29)", "package_ndc": "0054-0021-29", "marketing_start_date": "20041028"}], "brand_name": "Lithium Carbonate", "product_id": "0054-0021_5e0351f3-360d-4044-a40a-a36f0008cf92", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Mood Stabilizer [EPC]"], "product_ndc": "0054-0021", "generic_name": "Lithium Carbonate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lithium Carbonate", "active_ingredients": [{"name": "LITHIUM CARBONATE", "strength": "300 mg/1"}], "application_number": "ANDA076832", "marketing_category": "ANDA", "marketing_start_date": "20041028", "listing_expiration_date": "20261231"}