What is NDC 53746-101?

53746-101 is the product NDC for Gabapentin, Gabapentin 100 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Gabapentin?

561 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Gabapentin NDC 53746-101 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0101Add 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
53746-101-01	5374601010153746010101	100 CAPSULE in 1 BOTTLE (53746-101-01)Marketed from Nov 24, 2009
53746-101-05	5374601010553746010105	500 CAPSULE in 1 BOTTLE (53746-101-05)Marketed from Nov 24, 2009
53746-101-10	5374601011053746010110	1000 CAPSULE in 1 BOTTLE (53746-101-10)Marketed from Nov 24, 2009
53746-101-30	5374601013053746010130	30 CAPSULE in 1 BOTTLE (53746-101-30)Marketed from Nov 24, 2009

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): Gabapentin
Generic name (nonproprietary): gabapentin
Active ingredients: Gabapentin — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 53746
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078428
Marketing start: Nov 24, 2009
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 53746-101_10e5f9be-7920-4775-801b-e1c32b996410SPL ID 10e5f9be-7920-4775-801b-e1c32b996410SPL set ID b11dbff5-ceee-4a63-a093-f6efebdc2f6fRxCUI 310430, 310431, 310432UNII 6CW7F3G59XUPC 0353746101303, 0353746102300, 0353746103307

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

N453746010101 followed by a unit qualifier and the quantity

Package 53746-0101-01. 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 Feb 3, 2021.

Indications (excerpt from the label)

Gabapentin capsules are indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin capsules are indicated for: Postherpetic neuralgia in adults (1) Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53746-101

What is NDC 53746-101?: 53746-101 is the product NDC for Gabapentin, Gabapentin 100 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Gabapentin.
What is the active ingredient?: Gabapentin.
Who is the labeler?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gabapentin?: 561 other product NDCs are listed under this name. See all Gabapentin 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 Gabapentin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Gabapentin	Gabapentin 800 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-943	60760-0943-3060760-0943-90
gabapentin	Gabapentin 300 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4763	70518-4763-00
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-0581	55154-0581-00
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0595	80425-0595-0180425-0595-0280425-0595-03+1 more
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4746	70518-4746-0070518-4746-0170518-4746-02+1 more
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4742	70518-4742-0070518-4742-02
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4740	70518-4740-0070518-4740-01
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-0580	55154-0580-00
Gabapentin	Gabapentin 600 mg/1	Tablet, CoatedOral	Coupler LLC	67046-1233	67046-1233-03
Gabapentin	Gabapentin 200 mg/1	CapsuleOral	Trifluent Pharma, LLC	73352-231	73352-0231-01

All 562 Gabapentin NDCs

Other NDCs under ANDA 078428

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

FDA NDC Directory listings under ANDA 078428
Product	Strength	Form · route	Labeler	Product NDC
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Amneal Pharmaceuticals of New York LLC	53746-102
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	Amneal Pharmaceuticals of New York LLC	53746-103
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Clinical Solutions Wholesale, LLC	58118-1102
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	Clinical Solutions Wholesale, LLC	58118-1103
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Clinical Solutions Wholesale, LLC	58118-2101
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-7306
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Amneal Pharmaceuticals LLC	65162-101
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Amneal Pharmaceuticals LLC	65162-102
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	Amneal Pharmaceuticals LLC	65162-103
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-0214
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-0220
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-0820
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1813
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Unit Dose Solutions, Inc.	87441-034