Prescription drug · ANDA

Galantamine NDC 57237-051

Galantamine hydrobromide 12 mg/1 · Tablet, Film coated · Oral · Rising Pharma Holdings, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)57237-051Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57237-0051Add 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
57237-051-605723700516060 TABLET, FILM COATED in 1 BOTTLE (57237-051-60)Marketed from Mar 29, 2011

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
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 57237
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090957
Marketing start
Listing expires
Other FDA classes
Cholinesterase Inhibitors (Mechanism)
Identifiers
Product ID 57237-051_f59a93d6-9a01-40ad-a9ef-4eaacff23b79SPL ID f59a93d6-9a01-40ad-a9ef-4eaacff23b79SPL set ID a0dc1a93-b7b8-4179-8ea7-ceecbe1ef243RxCUI 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

N457237005160 followed by a unit qualifier and the quantity

Package 57237-0051-60. 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 tablets 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)

About NDC 57237-051

What is NDC 57237-051?
57237-051 is the product NDC for Galantamine, Galantamine hydrobromide 12 mg/1 tablet, film coated, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Galantamine.
What is the active ingredient?
Galantamine hydrobromide.
Who is the labeler?
Rising Pharma Holdings, Inc., NDC labeler code 57237. 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?
20 other product NDCs are listed under this name. See all Galantamine 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
GalantamineGalantamine hydrobromide 4 mg/1Tablet, Film coatedOralUpsher-Smith Laboratories, LLC24979-72224979-0722-04
GalantamineGalantamine hydrobromide 8 mg/1Tablet, Film coatedOralUpsher-Smith Laboratories, LLC24979-72324979-0723-04
GalantamineGalantamine hydrobromide 12 mg/1Tablet, Film coatedOralUpsher-Smith Laboratories, LLC24979-72424979-0724-04
GalantamineGalantamine hydrobromide 4 mg/1Tablet, Film coatedOralSlate Run Pharmaceuticals, LLC70436-00470436-0004-06
GalantamineGalantamine hydrobromide 8 mg/1Tablet, Film coatedOralSlate Run Pharmaceuticals, LLC70436-00570436-0005-06
GalantamineGalantamine hydrobromide 12 mg/1Tablet, Film coatedOralSlate Run Pharmaceuticals, LLC70436-00670436-0006-06
GalantamineGalantamine hydrobromide 8 mg/1Capsule, Extended releaseOralAurobindo Pharma Limited65862-74465862-0744-0165862-0744-0565862-0744-30+2 more
GalantamineGalantamine hydrobromide 16 mg/1Capsule, Extended releaseOralAurobindo Pharma Limited65862-74565862-0745-0165862-0745-0565862-0745-30+2 more
GalantamineGalantamine hydrobromide 24 mg/1Capsule, Extended releaseOralAurobindo Pharma Limited65862-74665862-0746-0165862-0746-0565862-0746-30+2 more
GalantamineGalantamine hydrobromide 4 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-72968084-0729-21

All 21 Galantamine NDCs

Other NDCs under ANDA 090957

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

FDA NDC Directory listings under ANDA 090957
ProductStrengthForm · routeLabelerProduct NDC
GalantamineGalantamine hydrobromide 4 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2766
GalantamineGalantamine hydrobromide 4 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-729
GalantamineGalantamine hydrobromide 4 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-458
GalantamineGalantamine hydrobromide 8 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-459
GalantamineGalantamine hydrobromide 12 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-460
GalantamineGalantamine hydrobromide 8 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2566
GalantamineGalantamine hydrobromide 4 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-049
GalantamineGalantamine hydrobromide 8 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-050

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Galantamine NDC 57237-051 | National Drug Code | Med-Code