What is NDC 0054-0021?

0054-0021 is the product NDC for Lithium Carbonate, Lithium carbonate 300 mg/1 tablet, extended release, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lithium Carbonate?

61 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lithium Carbonate NDC 0054-0021 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0021Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0021Add 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
0054-0021-25	00054002125	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0021-25)Marketed from Oct 28, 2004
0054-0021-29	00054002129	500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0021-29)Marketed from Oct 28, 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 — 300 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076832
Marketing start: Oct 28, 2004
Listing expires: Dec 31, 2026
Identifiers: Product ID 0054-0021_5e0351f3-360d-4044-a40a-a36f0008cf92SPL ID 5e0351f3-360d-4044-a40a-a36f0008cf92SPL set ID c612b6c5-eeb9-4fdd-8c85-bb3d2147cd1eRxCUI 197891UNII 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

N400054002125 followed by a unit qualifier and the quantity

Package 00054-0021-25. 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 Jul 28, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS Lithium carbonate is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium carbonate is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. 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 episod…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0054-0021

What is NDC 0054-0021?: 0054-0021 is the product NDC for Lithium Carbonate, Lithium carbonate 300 mg/1 tablet, extended release, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lithium Carbonate.
What is the active ingredient?: Lithium carbonate.
Who is the labeler?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lithium Carbonate?: 61 other product NDCs are listed under this name. See all Lithium Carbonate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Lithium Carbonate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lithium Carbonate	Lithium carbonate 300 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0886	00054-0886-2500054-0886-31
Lithium Carbonate	Lithium carbonate 150 mg/1	Capsule, Gelatin coatedOral	Hikma Pharmaceuticals USA Inc.	0054-0887	00054-0887-25
Lithium Carbonate	Lithium carbonate 300 mg/1	Capsule, Gelatin coatedOral	Hikma Pharmaceuticals USA Inc.	0054-0890	00054-0890-2500054-0890-31
Lithium Carbonate	Lithium carbonate 600 mg/1	Capsule, Gelatin coatedOral	Hikma Pharmaceuticals USA Inc.	0054-0891	00054-0891-25
lithium carbonate	Lithium carbonate 150 mg/1	CapsuleOral	Coupler LLC	67046-1690	67046-1690-03
Lithium Carbonate	Lithium carbonate 450 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4678	70518-4678-00
Lithium Carbonate	Lithium carbonate 600 mg/1	CapsuleOral	American Health Packaging	60687-964	60687-0964-21
Lithium Carbonate	Lithium carbonate 150 mg/1	CapsuleOral	Coupler LLC	67046-0547	67046-0547-03
lithium carbonate	Lithium carbonate 150 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4627	70518-4627-00
Lithium Carbonate	Lithium carbonate 300 mg/1	Tablet, Film coated, Extended releaseOral	Coupler LLC	67046-1575	67046-1575-03

All 62 Lithium Carbonate NDCs

Other NDCs under ANDA 076832

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

FDA NDC Directory listings under ANDA 076832
Product	Strength	Form · route	Labeler	Product NDC
Lithium Carbonate	Lithium carbonate 300 mg/1	Tablet, Extended releaseOral	American Health Packaging	68084-640
Lithium Carbonate	Lithium carbonate 300 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-3681
Lithium Carbonate	Lithium carbonate 300 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-171