NDC codes

FDA NDC Directory
Product NDC (as listed)83301-0004Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83301-0004Add 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
83301-0004-18330100040183301000401100 CAPSULE in 1 BOTTLE, PLASTIC (83301-0004-1)Marketed from May 1, 2023
83301-0004-28330100040283301000402500 CAPSULE in 1 BOTTLE, PLASTIC (83301-0004-2)Marketed from May 1, 2023
83301-0004-383301000403833010004031000 CAPSULE in 1 BOTTLE, PLASTIC (83301-0004-3)Marketed from May 1, 2023

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 — 300 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Mullan Pharmaceutical Inc.NDC labeler code 83301
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075477
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 83301-0004_3ce59317-9cf6-5ae5-e063-6394a90aba6cSPL ID 3ce59317-9cf6-5ae5-e063-6394a90aba6cSPL set ID 74474aa4-4859-42d2-92d8-f23f18b34e04RxCUI 310430, 310431, 310432UNII 6CW7F3G59XUPC 0383301000437, 0383301000338, 0383301000413, 0383301000314, 0383301000512, 0383301000529, 0383301000321, 0383301000420

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

N483301000401 followed by a unit qualifier and the quantity

Package 83301-0004-01. 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)

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 83301-0004

What is NDC 83301-0004?
83301-0004 is the product NDC for Gabapentin, Gabapentin 300 mg/1 capsule, listed with the FDA by Mullan Pharmaceutical Inc.. It has 3 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?
Mullan Pharmaceutical Inc., NDC labeler code 83301. 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.70518-474070518-4740-0070518-4740-01
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 075477

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

FDA NDC Directory listings under ANDA 075477
ProductStrengthForm · routeLabelerProduct NDC
GabapentinGabapentin 300 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-3527
GabapentinGabapentin 100 mg/1CapsuleOralWestminster Pharmaceuticals, LLC69367-343
GabapentinGabapentin 300 mg/1CapsuleOralWestminster Pharmaceuticals, LLC69367-344
GabapentinGabapentin 400 mg/1CapsuleOralWestminster Pharmaceuticals, LLC69367-345
GabapentinGabapentin 300 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0196
GabapentinGabapentin 100 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0199
GabapentinGabapentin 400 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0286
GabapentinGabapentin 300 mg/1CapsuleOralProficient Rx LP82804-217
GabapentinGabapentin 100 mg/1CapsuleOralProficient Rx LP82804-226
GabapentinGabapentin 100 mg/1CapsuleOralMullan Pharmaceutical Inc.83301-0003
GabapentinGabapentin 400 mg/1CapsuleOralMullan Pharmaceutical Inc.83301-0005

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