NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0097Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0097Add 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
80425-0097-1804250097018042500970130 TABLET, FILM COATED in 1 BOTTLE (80425-0097-1)Marketed from Oct 6, 2011
80425-0097-2804250097028042500970260 TABLET, FILM COATED in 1 BOTTLE (80425-0097-2)Marketed from Oct 6, 2011
80425-0097-3804250097038042500970390 TABLET, FILM COATED in 1 BOTTLE (80425-0097-3)Marketed from Oct 6, 2011
80425-0097-48042500970480425009704120 TABLET, FILM COATED in 1 BOTTLE (80425-0097-4)Marketed from Oct 6, 2011

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 — 600 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200651
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 80425-0097_2a998d83-7bad-3f5e-e063-6294a90acd3dSPL ID 2a998d83-7bad-3f5e-e063-6294a90acd3dSPL set ID b37b1dcc-c7e9-8845-e053-2995a90a089eRxCUI 310433UNII 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

N480425009701 followed by a unit qualifier and the quantity

Package 80425-0097-01. 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 .

Indications (excerpt from the label)

1. Indications and Usage Section Gabapentin tablets 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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0097

What is NDC 80425-0097?
80425-0097 is the product NDC for Gabapentin, Gabapentin 600 mg/1 tablet, film coated, listed with the FDA by Advanced Rx of 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?
Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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 200651

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

FDA NDC Directory listings under ANDA 200651
ProductStrengthForm · routeLabelerProduct NDC
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6823
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7108
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-330
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-332
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6854
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6855
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-3357
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-3366
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralProficient Rx LP63187-148
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-523
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2323
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2356
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2616
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2701
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2719
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2765
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2819
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralDIRECT RX72189-092
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0036
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0158

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