NDC codes

FDA NDC Directory
Product NDC (as listed)76282-627Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76282-0627Add 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
76282-627-017628206270176282062701100 CAPSULE in 1 BOTTLE (76282-627-01)Marketed from Sep 13, 2018
76282-627-057628206270576282062705500 CAPSULE in 1 BOTTLE (76282-627-05)Marketed from Sep 13, 2018
76282-627-187628206271876282062718180 CAPSULE in 1 BOTTLE (76282-627-18)Marketed from Sep 13, 2018
76282-627-277628206272776282062727270 CAPSULE in 1 BOTTLE (76282-627-27)Marketed from Sep 13, 2018
76282-627-30762820627307628206273030 CAPSULE in 1 BOTTLE (76282-627-30)Marketed from Sep 13, 2018
76282-627-60762820627607628206276060 CAPSULE in 1 BOTTLE (76282-627-60)Marketed from Sep 13, 2018
76282-627-90762820627907628206279090 CAPSULE in 1 BOTTLE (76282-627-90)Marketed from Sep 13, 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
Exelan Pharmaceuticals, Inc.NDC labeler code 76282
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 76282-627_5e0a57d7-9068-43d3-be26-96f646720fdeSPL ID 5e0a57d7-9068-43d3-be26-96f646720fdeSPL set ID 41d1ead3-046e-4abf-ae0a-cb126a1f5848RxCUI 310430, 310431, 310432UNII 6CW7F3G59XUPC 0376282323909, 0376282627182, 0376282323053, 0376282321189, 0376282627304, 0376282627908, 0376282627601, 0376282323275, 0376282321271, 0376282321059, 0376282321905, 0376282323015, 0376282321011, 0376282627274, 0376282627014

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

N476282062701 followed by a unit qualifier and the quantity

Package 76282-0627-01. 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 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 76282-627

What is NDC 76282-627?
76282-627 is the product NDC for Gabapentin, Gabapentin 300 mg/1 capsule, listed with the FDA by Exelan Pharmaceuticals, Inc.. 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?
Exelan Pharmaceuticals, Inc., NDC labeler code 76282. 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 300 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-185
GabapentinGabapentin 100 mg/1CapsuleOralBryant Ranch Prepack71335-0073
GabapentinGabapentin 400 mg/1CapsuleOralProficient Rx LP63187-909
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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