Lithium Carbonate ER (lithium carbonate) NDC 42291-496

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-496Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0496Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42291-496-01	42291049601	100 TABLET in 1 BOTTLE (42291-496-01)Marketed from Feb 25, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Lithium Carbonate ERSuffix: ER
Generic name (nonproprietary): lithium carbonate
Active ingredients: Lithium carbonate — 450 mg/1
Dosage form: Tablet
Route: Oral
Labeler: AvKARE
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091616
Marketing start: Feb 25, 2022
Listing expires: Dec 31, 2027
Identifiers: Product ID 42291-496_485f83f8-8405-eae8-e063-6294a90a3c33SPL ID 485f83f8-8405-eae8-e063-6294a90a3c33SPL set ID d8ddff4d-2b77-a8f2-e053-2a95a90a5fc0RxCUI 197892UNII 2BMD2GNA4V
Pharmacologic class: Mood Stabilizer

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N442291049601 followed by a unit qualifier and the quantity

Package 42291-0496-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 14, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Lithium Carbonate Extended-Release Tablets are indicated in the treatment of manic episodes of manic-depressive illness. Maintenance therapy prevents or diminishes the intensity of subsequent episodes in those manic-depressive patients with a history of mania. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness and possibly hostility. When given to a patient experiencing a manic episode, Lithium Carbonate Extended-Release Tablets may produce a normalization of symptomatology within 1 to 3 weeks.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091616

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 091616
Product	Strength	Form · route	Labeler	Product NDC
Lithium Carbonate ERlithium carbonate	Lithium carbonate 450 mg/1	TabletOral	Coupler LLC	67046-0408
Lithium Carbonate ERlithium carbonate	Lithium carbonate 450 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-224
Lithium Carbonate ERlithium carbonate	Lithium carbonate 450 mg/1	TabletOral	REMEDYREPACK INC.	70518-4589