NDC codes

FDA NDC Directory
Product NDC (as listed)68382-204Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68382-0204Add 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
68382-204-016838202040168382020401100 TABLET, FILM COATED in 1 BOTTLE (68382-204-01)Marketed from Oct 16, 2012
68382-204-056838202040568382020405500 TABLET, FILM COATED in 1 BOTTLE (68382-204-05)Marketed from Oct 16, 2012
68382-204-1068382020410683820204101000 TABLET, FILM COATED in 1 BOTTLE (68382-204-10)Marketed from Oct 16, 2012

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 — 600 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078926
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 68382-204_e85a763f-472b-492b-bf25-a30251b9b50bSPL ID e85a763f-472b-492b-bf25-a30251b9b50bSPL set ID 310ce005-5a24-489a-b23c-d42ab6a3bfedRxCUI 310433, 310434UNII 6CW7F3G59XUPC 0368382204011, 0368382205018

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

N468382020401 followed by a unit qualifier and the quantity

Package 68382-0204-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 68382-204

What is NDC 68382-204?
68382-204 is the product NDC for Gabapentin, Gabapentin 600 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA 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?
Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 078926

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

FDA NDC Directory listings under ANDA 078926
ProductStrengthForm · routeLabelerProduct NDC
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-611
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-8189
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-8193
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-507
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-518
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-705
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-706
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-205
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-127

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