What is NDC 43353-081?

43353-081 is the product NDC for Gabapentin, Gabapentin 400 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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 43353-081 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-081Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0081Add 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
43353-081-60	4335300816043353008160	90 CAPSULE in 1 BOTTLE (43353-081-60)Marketed from Jul 11, 2015
43353-081-80	4335300818043353008180	180 CAPSULE in 1 BOTTLE (43353-081-80)Marketed from Nov 7, 2015
43353-081-92	4335300819243353008192	270 CAPSULE in 1 BOTTLE (43353-081-92)Marketed from Jan 28, 2016
43353-081-94	4335300819443353008194	360 CAPSULE in 1 BOTTLE (43353-081-94)Marketed from Nov 8, 2015

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 — 400 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075350
Marketing start: Mar 17, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 43353-081_c53f4d79-df8d-42b8-86e3-bd6181049abcSPL ID c53f4d79-df8d-42b8-86e3-bd6181049abcSPL set ID 86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49RxCUI 310431, 310432UNII 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

N443353008160 followed by a unit qualifier and the quantity

Package 43353-0081-60. 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 Jun 20, 2016.

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 43353-081

What is NDC 43353-081?: 43353-081 is the product NDC for Gabapentin, Gabapentin 400 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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 075350

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

FDA NDC Directory listings under ANDA 075350
Product	Strength	Form · route	Labeler	Product NDC
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Teva Pharmaceuticals, Inc.	0480-3494
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	43353-075
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Actavis Pharma, Inc.	45963-555
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Actavis Pharma, Inc.	45963-556
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Proficient Rx LP	63187-988
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	Proficient Rx LP	71205-064
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-0351
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-072
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-055
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-014
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-015
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0032