What is NDC 42385-980?

42385-980 is the product NDC for Gabapentin, Gabapentin 800 mg/1 tablet, film coated, listed with the FDA by Laurus Labs Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.

Laurus Labs Limited, NDC labeler code 42385. 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 42385-980 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42385-980Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42385-0980Add 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
42385-980-01	42385098001	100 TABLET, FILM COATED in 1 BOTTLE (42385-980-01)Marketed from Apr 9, 2024
42385-980-05	42385098005	500 TABLET, FILM COATED in 1 BOTTLE (42385-980-05)Marketed from Apr 9, 2024
42385-980-11	42385098011	1000 TABLET, FILM COATED in 1 BOTTLE (42385-980-11)Marketed from Apr 9, 2024
42385-980-30	42385098030	30 TABLET, FILM COATED in 1 BOTTLE (42385-980-30)Marketed from Apr 9, 2024
42385-980-72	42385098072	10 BLISTER PACK in 1 CARTON (42385-980-72) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 9, 2024
42385-980-90	42385098090	90 TABLET, FILM COATED in 1 BOTTLE (42385-980-90)Marketed from Apr 9, 2024

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, Film coated
Route: Oral
Labeler: Laurus Labs LimitedNDC labeler code 42385
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217965
Marketing start: Apr 9, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 42385-980_5fd82a02-46ac-4312-a008-fa17e5cd3ffdSPL ID 5fd82a02-46ac-4312-a008-fa17e5cd3ffdSPL set ID 07aa1bcc-df05-44fa-92d4-63894e0e6cd6RxCUI 310430, 310431, 310432, 310433, 310434UNII 6CW7F3G59XUPC 0342385980301

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

N442385098001 followed by a unit qualifier and the quantity

Package 42385-0980-01. 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 May 28, 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 42385-980

What is NDC 42385-980?: 42385-980 is the product NDC for Gabapentin, Gabapentin 800 mg/1 tablet, film coated, listed with the FDA by Laurus Labs Limited. It has 6 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?: Laurus Labs Limited, NDC labeler code 42385. 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 300 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4763	70518-4763-00
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0595	80425-0595-0180425-0595-0280425-0595-03+1 more
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-0581	55154-0581-00
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 562 Gabapentin NDCs

Other NDCs under ANDA 217965

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

FDA NDC Directory listings under ANDA 217965
Product	Strength	Form · route	Labeler	Product NDC
Gabapentin	Gabapentin 600 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-979