lithium carbonate

Generic: lithium carbonate

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lithium carbonate
Generic Name lithium carbonate
Labeler coupler llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

lithium carbonate 300 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1575
Product ID 67046-1575_3dfedfb7-e561-bc6d-e063-6294a90ac562
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091544
Listing Expiration 2026-12-31
Marketing Start 2025-09-04

Pharmacologic Class

Classes
mood stabilizer [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461575
Hyphenated Format 67046-1575

Supplemental Identifiers

RxCUI
197891
UNII
2BMD2GNA4V

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 ANDA091544 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (67046-1575-3)
source: ndc

Packages (1)

Ingredients (1)

lithium carbonate (300 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3dfedfb7-e561-bc6d-e063-6294a90ac562", "openfda": {"unii": ["2BMD2GNA4V"], "rxcui": ["197891"], "spl_set_id": ["3dfeeb11-a096-ae17-e063-6294a90a9aae"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (67046-1575-3)", "package_ndc": "67046-1575-3", "marketing_start_date": "20250904"}], "brand_name": "Lithium Carbonate", "product_id": "67046-1575_3dfedfb7-e561-bc6d-e063-6294a90ac562", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Mood Stabilizer [EPC]"], "product_ndc": "67046-1575", "generic_name": "Lithium Carbonate", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lithium Carbonate", "active_ingredients": [{"name": "LITHIUM CARBONATE", "strength": "300 mg/1"}], "application_number": "ANDA091544", "marketing_category": "ANDA", "marketing_start_date": "20250904", "listing_expiration_date": "20261231"}