What is NDC 45865-216?

45865-216 is the product NDC for Gabapentin, Gabapentin 100 mg/1 capsule, listed with the FDA by Medsource Pharmaceuticals. It has 4 package NDCs, shown above in 10- and 11-digit form.

Medsource Pharmaceuticals, NDC labeler code 45865. 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 45865-216 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)45865-216Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45865-0216Add 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
45865-216-30	4586502163045865021630	30 CAPSULE in 1 BOTTLE (45865-216-30)Marketed from Sep 15, 2022
45865-216-51	4586502165145865021651	120 CAPSULE in 1 BOTTLE (45865-216-51)Marketed from Jun 2, 2022
45865-216-60	4586502166045865021660	60 CAPSULE in 1 BOTTLE (45865-216-60)Marketed from Feb 23, 2024
45865-216-90	4586502169045865021690	90 CAPSULE in 1 BOTTLE (45865-216-90)Marketed from Jun 13, 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 — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Medsource PharmaceuticalsNDC labeler code 45865
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206943
Marketing start: May 14, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 45865-216_1277f18a-a854-3b06-e063-6294a90a88b2SPL ID 1277f18a-a854-3b06-e063-6294a90a88b2SPL set ID 1278512b-1493-db65-e063-6394a90ab161RxCUI 310430UNII 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

N445865021630 followed by a unit qualifier and the quantity

Package 45865-0216-30. 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 Feb 28, 2024.

Indications (excerpt from the label)

Gabapentin Capsules, USP 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, USP 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 45865-216

What is NDC 45865-216?: 45865-216 is the product NDC for Gabapentin, Gabapentin 100 mg/1 capsule, listed with the FDA by Medsource Pharmaceuticals. 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?: Medsource Pharmaceuticals, NDC labeler code 45865. 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 206943

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

FDA NDC Directory listings under ANDA 206943
Product	Strength	Form · route	Labeler	Product NDC
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1093
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	ADVANCED RX OF TENNESSEE, LLC	80425-0031
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	St. Mary's Medical Park Pharmacy	60760-939
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	St. Mary's Medical Park Pharmacy	60760-940
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2741
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1169
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-4978
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2280
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2279
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-2876
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2139
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	Strides Pharma Science Limited	64380-731
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2138
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2140
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1348
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Strides Pharma Science Limited	64380-753
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4740
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Strides Pharma Science Limited	64380-754
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4742
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Proficient Rx LP	71205-317

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