What is NDC 0054-0137?

0054-0137 is the product NDC for Galantamine Hydrobromide, Galantamine hydrobromide 4 mg/mL solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, 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 Galantamine Hydrobromide?

9 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Galantamine Hydrobromide NDC 0054-0137

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0137Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0137Add 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
0054-0137-49	0005401374900054013749	100 mL in 1 BOTTLE (0054-0137-49)Marketed from Aug 14, 2009

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): Galantamine Hydrobromide
Generic name (nonproprietary): galantamine hydrobromide
Active ingredients: Galantamine hydrobromide — 4 mg/mL
Dosage form: Solution
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 078185
Marketing start: Aug 14, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Cholinesterase Inhibitors (Mechanism)
Identifiers: Product ID 0054-0137_b2bf3efc-7521-4ff7-b77c-6e312e34b3c4SPL ID b2bf3efc-7521-4ff7-b77c-6e312e34b3c4SPL set ID d5b0e225-e94d-4324-afb2-b6e51c949dd0RxCUI 860901UNII MJ4PTD2VVW
Pharmacologic class: Cholinesterase Inhibitor

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

N400054013749 followed by a unit qualifier and the quantity

Package 00054-0137-49. 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 Oct 25, 2023.

Indications (excerpt from the label)

Galantamine is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0054-0137

What is NDC 0054-0137?: 0054-0137 is the product NDC for Galantamine Hydrobromide, Galantamine hydrobromide 4 mg/mL solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Galantamine Hydrobromide.
What is the active ingredient?: Galantamine hydrobromide.
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 Galantamine Hydrobromide?: 9 other product NDCs are listed under this name. See all Galantamine Hydrobromide 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 Galantamine Hydrobromide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Galantamine Hydrobromide	Galantamine hydrobromide 8 mg/1	Capsule, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	47335-835	47335-0835-0847335-0835-1847335-0835-83+1 more
Galantamine Hydrobromide	Galantamine hydrobromide 16 mg/1	Capsule, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	47335-836	47335-0836-0847335-0836-1847335-0836-83+1 more
Galantamine Hydrobromide	Galantamine hydrobromide 24 mg/1	Capsule, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	47335-837	47335-0837-0847335-0837-1847335-0837-83+1 more
Galantamine Hydrobromide	Galantamine hydrobromide 24 mg/1	Capsule, Extended releaseOral	Bryant Ranch Prepack	63629-2363	63629-2363-01
Galantamine Hydrobromide	Galantamine hydrobromide 8 mg/1	Capsule, Extended releaseOral	Bryant Ranch Prepack	63629-2364	63629-2364-01
Galantamine Hydrobromide	Galantamine hydrobromide 16 mg/1	Capsule, Extended releaseOral	Bryant Ranch Prepack	63629-2365	63629-2365-01
Galantamine Hydrobromide	Galantamine hydrobromide 8 mg/1	Capsule, Extended releaseOral	Bryant Ranch Prepack	72162-1446	72162-1446-03
Galantamine Hydrobromide	Galantamine hydrobromide 16 mg/1	Capsule, Extended releaseOral	Bryant Ranch Prepack	72162-1447	72162-1447-03
Galantamine Hydrobromide	Galantamine hydrobromide 24 mg/1	Capsule, Extended releaseOral	Bryant Ranch Prepack	72162-1448	72162-1448-03