What is NDC 85534-0003?

85534-0003 is the product NDC for Gabapentin, Gabapentin 100 mg/1 capsule, listed with the FDA by HAWAII REPACK, INC.. It has 4 package NDCs, shown above in 10- and 11-digit form.

HAWAII REPACK, INC., NDC labeler code 85534. 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?

558 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 85534-0003 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)85534-0003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85534-0003Add 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
85534-0003-0	85534000300	30 CAPSULE in 1 BOTTLE, PLASTIC (85534-0003-0)Marketed from Jul 2, 2026
85534-0003-1	85534000301	60 CAPSULE in 1 BOTTLE, PLASTIC (85534-0003-1)Marketed from Jul 2, 2026
85534-0003-2	85534000302	90 CAPSULE in 1 BOTTLE, PLASTIC (85534-0003-2)Marketed from Jul 2, 2026
85534-0003-3	85534000303	120 CAPSULE in 1 BOTTLE, PLASTIC (85534-0003-3)Marketed from Jul 2, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: HAWAII REPACK, INC.NDC labeler code 85534
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204989
Marketing start: Feb 18, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 85534-0003_559e72cb-a7f3-e1ed-e063-6294a90ad90aSPL ID 559e72cb-a7f3-e1ed-e063-6294a90ad90aSPL set ID dd7adad2-e2f5-4b43-90a4-522bce0be5b3RxCUI 310430, 310431, 310432UNII 6CW7F3G59X

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

N485534000300 followed by a unit qualifier and the quantity

Package 85534-0003-00. 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 2, 2026.

Indications (excerpt from the label)

Gabapentin is 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 85534-0003

What is NDC 85534-0003?: 85534-0003 is the product NDC for Gabapentin, Gabapentin 100 mg/1 capsule, listed with the FDA by HAWAII REPACK, INC.. 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?: HAWAII REPACK, INC., NDC labeler code 85534. 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?: 558 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 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
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4742	70518-4742-00
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
Gabapentin	Gabapentin 600 mg/1	TabletOral	Coupler LLC	67046-1086	67046-1086-03

All 559 Gabapentin NDCs

Other NDCs under ANDA 204989

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

FDA NDC Directory listings under ANDA 204989
Product	Strength	Form · route	Labeler	Product NDC
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Medsource Pharmaceuticals	45865-194
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	A-S Medication Solutions	50090-7672
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	A-S Medication Solutions	50090-7673
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	A-S Medication Solutions	50090-7674
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	A-S Medication Solutions	50090-7675
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc.	50228-179
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc.	50228-180
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc.	50228-181
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Quality Care Products, LLC	55700-949
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Quality Care Products, LLC	55700-950
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	St. Mary's Medical Park Pharmacy	60760-740
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	St. Mary's Medical Park Pharmacy	60760-741
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8484
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8485
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8486
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8487
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8488
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Coupler LLC	67046-1257
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Coupler LLC	67046-1284
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-2366

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