Prescription drug · ANDA

Gabapentin NDC 65862-524

Gabapentin 800 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)65862-524Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0524Add 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
65862-524-0165862052401100 TABLET, FILM COATED in 1 BOTTLE (65862-524-01)Marketed from Oct 6, 2011
65862-524-0565862052405500 TABLET, FILM COATED in 1 BOTTLE (65862-524-05)Marketed from Oct 6, 2011
65862-524-31658620524311700 TABLET, FILM COATED in 1 BOTTLE (65862-524-31)Marketed from Oct 6, 2011
65862-524-906586205249090 TABLET, FILM COATED in 1 BOTTLE (65862-524-90)Marketed from Oct 6, 2011

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 — 800 mg/1
Dosage form
Tablet, Film coated
Route
Oral
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 65862-524_700d09f5-99cc-492d-ab49-442f674d9c5dSPL ID 700d09f5-99cc-492d-ab49-442f674d9c5dSPL set ID 25cf6c40-a239-4dd0-9cad-28da84d285dbRxCUI 310433, 310434UNII 6CW7F3G59XUPC 0365862524010, 0365862523013

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

N465862052401 followed by a unit qualifier and the quantity

Package 65862-0524-01. 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 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 Gabapentin tablets are 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)

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 800 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7108
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 coatedOralDIRECT RX72189-092
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-072
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-071
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2323
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2356
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2701
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2719
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6854
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6855
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0036
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-330
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-332
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2765
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-523
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2616
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0097
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6823

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