NDC codes

FDA NDC Directory
Product NDC (as listed)71610-185Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0185Add 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 NDC11-digit (billing)PackageCopy
71610-185-30716100185307161001853030 CAPSULE in 1 BOTTLE (71610-185-30)Marketed from Nov 2, 2018
71610-185-53716100185537161001855360 CAPSULE in 1 BOTTLE (71610-185-53)Marketed from Nov 2, 2018
71610-185-60716100185607161001856090 CAPSULE in 1 BOTTLE (71610-185-60)Marketed from Nov 12, 2018
71610-185-707161001857071610018570120 CAPSULE in 1 BOTTLE (71610-185-70)Marketed from Nov 2, 2018
71610-185-807161001858071610018580180 CAPSULE in 1 BOTTLE (71610-185-80)Marketed from Nov 12, 2018
71610-185-927161001859271610018592270 CAPSULE in 1 BOTTLE (71610-185-92)Marketed from Nov 12, 2018
71610-185-947161001859471610018594360 CAPSULE in 1 BOTTLE (71610-185-94)Marketed from Nov 12, 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 090705
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 71610-185_e1f89ae6-021d-4fcd-ad58-27f2be19fd6eSPL ID e1f89ae6-021d-4fcd-ad58-27f2be19fd6eSPL set ID a900bafb-8f49-4a01-ba7f-4fb228ec0253RxCUI 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

N471610018530 followed by a unit qualifier and the quantity

Package 71610-0185-30. 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 .

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 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 71610-185

What is NDC 71610-185?
71610-185 is the product NDC for Gabapentin, Gabapentin 300 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 7 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
GabapentinGabapentin 800 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-94360760-0943-3060760-0943-90
gabapentinGabapentin 300 mg/1CapsuleOralREMEDYREPACK INC.70518-476370518-4763-00
GabapentinGabapentin 100 mg/1CapsuleOralCardinal Health 107, LLC55154-058155154-0581-00
GabapentinGabapentin 100 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-059580425-0595-0180425-0595-0280425-0595-03+1 more
GabapentinGabapentin 300 mg/1CapsuleOralREMEDYREPACK INC.70518-474670518-4746-0070518-4746-0170518-4746-02+1 more
GabapentinGabapentin 100 mg/1CapsuleOralREMEDYREPACK INC.70518-474270518-4742-0070518-4742-02
GabapentinGabapentin 400 mg/1CapsuleOralREMEDYREPACK INC.70518-474070518-4740-00
GabapentinGabapentin 300 mg/1CapsuleOralCardinal Health 107, LLC55154-058055154-0580-00
GabapentinGabapentin 600 mg/1Tablet, CoatedOralCoupler LLC67046-123367046-1233-03
GabapentinGabapentin 200 mg/1CapsuleOralTrifluent Pharma, LLC73352-23173352-0231-01

All 562 Gabapentin NDCs

Other NDCs under ANDA 090705

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

FDA NDC Directory listings under ANDA 090705
ProductStrengthForm · routeLabelerProduct NDC
GabapentinGabapentin 300 mg/1CapsuleOralCipla USA Inc.69097-943
GabapentinGabapentin 300 mg/1CapsuleOralAsclemed USA, Inc.76420-020
GabapentinGabapentin 400 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-166
GabapentinGabapentin 100 mg/1CapsuleOralBryant Ranch Prepack71335-0073
GabapentinGabapentin 400 mg/1CapsuleOralProficient Rx LP63187-909
GabapentinGabapentin 300 mg/1CapsuleOralExelan Pharmaceuticals, Inc.76282-627
GabapentinGabapentin 100 mg/1CapsuleOralREMEDYREPACK INC.70518-4261
GabapentinGabapentin 400 mg/1CapsuleOralCipla USA Inc.69097-815
GabapentinGabapentin 100 mg/1CapsuleOralCipla USA Inc.69097-813
GabapentinGabapentin 300 mg/1CapsuleOralBryant Ranch Prepack71335-1454
GabapentinGabapentin 300 mg/1CapsuleOralBryant Ranch Prepack71335-1453
GabapentinGabapentin 100 mg/1CapsuleOralProficient Rx LP63187-392
GabapentinGabapentin 100 mg/1CapsuleOralExelan Pharmaceuticals, Inc.76282-321
GabapentinGabapentin 400 mg/1CapsuleOralExelan Pharmaceuticals, Inc.76282-323

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