Prescription drug · ANDA

Galantamine NDC 51407-908

Galantamine hydrobromide 12 mg/1 · Tablet, Film coated · Oral · Golden State Medical Supply, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)51407-908Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51407-0908Add 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 NDC11-digit (billing)PackageCopy
51407-908-605140709086060 TABLET, FILM COATED in 1 BOTTLE (51407-908-60)Marketed from Apr 15, 2024

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)
Galantamine
Generic name (nonproprietary)
galantamine
Active ingredients
Galantamine hydrobromide — 12 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077604
Marketing start
Listing expires
Other FDA classes
Cholinesterase Inhibitors (Mechanism)
Identifiers
Product ID 51407-908_547b40f4-a2d2-d9ab-e063-6294a90a8f81SPL ID 547b40f4-a2d2-d9ab-e063-6294a90a8f81SPL set ID 18fd8860-d9ab-1b17-e063-6294a90aad9aRxCUI 310436, 310437, 579148UNII 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

N451407090860 followed by a unit qualifier and the quantity

Package 51407-0908-60. 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 .

Indications (excerpt from the label)

Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine Tables are 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)

Other NDCs under ANDA 077604

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

FDA NDC Directory listings under ANDA 077604
ProductStrengthForm · routeLabelerProduct NDC
GalantamineGalantamine hydrobromide 8 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-907
GalantamineGalantamine hydrobromide 4 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-906
GalantamineGalantamine hydrobromide 8 mg/1Tablet, Film coatedOralUpsher-Smith Laboratories, LLC24979-723
GalantamineGalantamine hydrobromide 4 mg/1Tablet, Film coatedOralUpsher-Smith Laboratories, LLC24979-722
GalantamineGalantamine hydrobromide 12 mg/1Tablet, Film coatedOralUpsher-Smith Laboratories, LLC24979-724
GalantamineGalantamine hydrobromide 12 mg/1Tablet, Film coatedOralSlate Run Pharmaceuticals, LLC70436-006
GalantamineGalantamine hydrobromide 4 mg/1Tablet, Film coatedOralSlate Run Pharmaceuticals, LLC70436-004
GalantamineGalantamine hydrobromide 8 mg/1Tablet, Film coatedOralSlate Run Pharmaceuticals, LLC70436-005

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Galantamine NDC 51407-908 | Med-Code