Lithium Carbonate NDC 0054-0020

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0020Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0020Add 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
0054-0020-25	00054002025	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0020-25)Marketed from Jan 13, 2004

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Generic name (nonproprietary): lithium carbonate
Active ingredients: Lithium carbonate — 450 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076691
Marketing start: Jan 13, 2004
Listing expires: Dec 31, 2026
Identifiers: Product ID 0054-0020_17dfc90a-8988-4e63-aaa0-9c88c4a7d1bfSPL ID 17dfc90a-8988-4e63-aaa0-9c88c4a7d1bfSPL set ID a226a88d-eb57-4c96-afda-939801bca0a9RxCUI 197892UNII 2BMD2GNA4VUPC 0300540020255
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

N400054002025 followed by a unit qualifier and the quantity

Package 00054-0020-25. 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 Jun 28, 2023. 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 076691

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

FDA NDC Directory listings under ANDA 076691
Product	Strength	Form · route	Labeler	Product NDC
Lithium Carbonate	Lithium carbonate 450 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4678
Lithium Carbonate	Lithium carbonate 450 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	43063-901
Lithium Carbonate	Lithium carbonate 450 mg/1	Tablet, Extended releaseOral	American Health Packaging	68084-655