What is NDC 71610-630?

71610-630 is the product NDC for Gabapentin, Gabapentin 800 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 8 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 71610-630 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-630Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0630Add 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
71610-630-30	7161006303071610063030	30 TABLET in 1 BOTTLE (71610-630-30)Marketed from Apr 20, 2022
71610-630-45	7161006304571610063045	45 TABLET in 1 BOTTLE (71610-630-45)Marketed from Apr 20, 2022
71610-630-53	7161006305371610063053	60 TABLET in 1 BOTTLE (71610-630-53)Marketed from Apr 20, 2022
71610-630-60	7161006306071610063060	90 TABLET in 1 BOTTLE (71610-630-60)Marketed from Apr 20, 2022
71610-630-70	7161006307071610063070	120 TABLET in 1 BOTTLE (71610-630-70)Marketed from Apr 20, 2022
71610-630-73	7161006307371610063073	135 TABLET in 1 BOTTLE (71610-630-73)Marketed from Apr 20, 2022
71610-630-80	7161006308071610063080	180 TABLET in 1 BOTTLE (71610-630-80)Marketed from Jan 25, 2022
71610-630-92	7161006309271610063092	270 TABLET in 1 BOTTLE (71610-630-92)Marketed from Jan 25, 2022

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 — 800 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214957
Marketing start: Oct 1, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 71610-630_12e0dcb9-e210-413b-9c77-cdeccd600e82SPL ID 12e0dcb9-e210-413b-9c77-cdeccd600e82SPL set ID 17988b64-723c-488d-befd-3e4e4cc44bd2RxCUI 310434UNII 6CW7F3G59X
Pharmacologic class: Anti-epileptic Agent

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

N471610063030 followed by a unit qualifier and the quantity

Package 71610-0630-30. 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 May 11, 2022.

Indications (excerpt from the label)

Gabapentin tablets 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 is 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 71610-630

What is NDC 71610-630?: 71610-630 is the product NDC for Gabapentin, Gabapentin 800 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 8 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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	70518-4740-00
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 214957

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

FDA NDC Directory listings under ANDA 214957
Product	Strength	Form · route	Labeler	Product NDC
Gabapentin	Gabapentin 600 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3445
Gabapentin	Gabapentin 600 mg/1	TabletOral	Direct_Rx	72189-471
Gabapentin	Gabapentin 800 mg/1	TabletOral	Clinical Solutions Wholesale, LLC	58118-1167
Gabapentin	Gabapentin 600 mg/1	TabletOral	Proficient Rx LP	82804-193
Gabapentin	Gabapentin 600 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-987
Gabapentin	Gabapentin 600 mg/1	TabletOral	Exelan Pharmaceuticals, Inc.	76282-706
Gabapentin	Gabapentin 800 mg/1	TabletOral	Exelan Pharmaceuticals, Inc.	76282-707
Gabapentin	Gabapentin 600 mg/1	TabletOral	Asclemed USA, Inc.	76420-836
Gabapentin	Gabapentin 800 mg/1	TabletOral	Asclemed USA, Inc.	76420-837
Gabapentin	Gabapentin 800 mg/1	TabletOral	Coupler LLC	67046-1667
Gabapentin	Gabapentin 600 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-166
Gabapentin	Gabapentin 800 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-167
Gabapentin	Gabapentin 800 mg/1	TabletOral	Proficient Rx LP	82804-249
Gabapentin	Gabapentin 800 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8468
Gabapentin	Gabapentin 600 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8476
Gabapentin	Gabapentin 600 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8488
Gabapentin	Gabapentin 800 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8790
Gabapentin	Gabapentin 800 mg/1	TabletOral	Bryant Ranch Prepack	71335-3057
Gabapentin	Gabapentin 600 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-621
Gabapentin	Gabapentin 600 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-255

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