What is NDC 71610-088?

71610-088 is the product NDC for Gabapentin, Gabapentin 300 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 5 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 71610-088 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-088Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0088Add 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
71610-088-53	7161000885371610008853	60 CAPSULE in 1 BOTTLE (71610-088-53)Marketed from Jun 21, 2018
71610-088-60	7161000886071610008860	90 CAPSULE in 1 BOTTLE (71610-088-60)Marketed from Jun 21, 2018
71610-088-80	7161000888071610008880	180 CAPSULE in 1 BOTTLE (71610-088-80)Marketed from Jun 21, 2018
71610-088-92	7161000889271610008892	270 CAPSULE in 1 BOTTLE (71610-088-92)Marketed from Jun 21, 2018
71610-088-94	7161000889471610008894	360 CAPSULE in 1 BOTTLE (71610-088-94)Marketed from Jun 21, 2018

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 — 300 mg/1
Dosage form: Capsule
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 090007
Marketing start: Dec 30, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 71610-088_0515dc32-e7fc-4208-9677-ec9dfad018f1SPL ID 0515dc32-e7fc-4208-9677-ec9dfad018f1SPL set ID 9d1b9121-c25a-4d28-91c5-5fc72f1167f4RxCUI 310431UNII 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

N471610008853 followed by a unit qualifier and the quantity

Package 71610-0088-53. 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 Jul 12, 2018.

Full label on DailyMed (opens in a new tab)

About NDC 71610-088

What is NDC 71610-088?: 71610-088 is the product NDC for Gabapentin, Gabapentin 300 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 5 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 090007

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

FDA NDC Directory listings under ANDA 090007
Product	Strength	Form · route	Labeler	Product NDC
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	MARKSANS PHARMA LIMITED	25000-103
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	MARKSANS PHARMA LIMITED	25000-104
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	MARKSANS PHARMA LIMITED	25000-105
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Bi-Coastal Pharma International LLC	42582-114
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Bi-Coastal Pharma International LLC	42582-115
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	Bi-Coastal Pharma International LLC	42582-116
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	TIME CAP LABORATORIES, INC	49483-605
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	TIME CAP LABORATORIES, INC	49483-606
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	TIME CAP LABORATORIES, INC	49483-607
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	DIRECT RX	61919-640
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-4784
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-5017
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-7024
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-2919
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-0993
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1490
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1991
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2005
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	DIRECT RX	72189-109
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	DIRECT RX	72189-113

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