NDC codes

FDA NDC Directory
Product NDC (as listed)68382-608Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68382-0608Add 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
68382-608-056838206080568382060805500 TABLET in 1 BOTTLE (68382-608-05)Marketed from Jan 25, 2024
68382-608-16683820608166838206081690 TABLET in 1 BOTTLE (68382-608-16)Marketed from Jan 25, 2024
68382-608-77683820608776838206087710 BLISTER PACK in 1 CARTON (68382-608-77) / 10 TABLET in 1 BLISTER PACK (68382-608-30)Marketed from Jan 25, 2024

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
Tablet
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 203934
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 68382-608_898c1710-d86c-4fbe-9a53-34661fcdb63aSPL ID 898c1710-d86c-4fbe-9a53-34661fcdb63aSPL set ID 3cfd04ab-e421-441f-a10e-e4dd1412974dRxCUI 1806380, 1806382, 2634743, 2634747, 2634751UNII 6CW7F3G59XUPC 0368382607164

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

N468382060805 followed by a unit qualifier and the quantity

Package 68382-0608-05. 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 tablet is indicated for the management of postherpetic neuralgia. Once-daily gabapentin tablets are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. Gabapentin tablet is indicated for the management of Postherpetic Neuralgia (PHN). Important Limitation Once-daily gabapentin tablets are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration (see Warnings and Precautions).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-608

What is NDC 68382-608?
68382-608 is the product NDC for gabapentin, Gabapentin 300 mg/1 tablet, 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 203934

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

FDA NDC Directory listings under ANDA 203934
ProductStrengthForm · routeLabelerProduct NDC
gabapentinGabapentin 450 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-355
gabapentinGabapentin 750 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-356
gabapentinGabapentin 900 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-357
gabapentinGabapentin 600 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-607
gabapentinGabapentin 300 mg/1TabletOralZydus Lifesciences Limited70771-1861
gabapentinGabapentin 600 mg/1TabletOralZydus Lifesciences Limited70771-1862
gabapentinGabapentin 450 mg/1TabletOralZydus Lifesciences Limited70771-1916
gabapentinGabapentin 750 mg/1TabletOralZydus Lifesciences Limited70771-1917
gabapentinGabapentin 900 mg/1TabletOralZydus Lifesciences Limited70771-1918

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