Prescription drug · ANDA

Gabapentin NDC 71610-044

Gabapentin 600 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)71610-044Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0044Add 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
71610-044-307161000443030 TABLET, FILM COATED in 1 BOTTLE (71610-044-30)Marketed from Jun 10, 2020
71610-044-457161000444545 TABLET, FILM COATED in 1 BOTTLE (71610-044-45)Marketed from Jun 10, 2020
71610-044-537161000445360 TABLET, FILM COATED in 1 BOTTLE (71610-044-53)Marketed from Jun 10, 2020
71610-044-607161000446090 TABLET, FILM COATED in 1 BOTTLE (71610-044-60)Marketed from Mar 23, 2018
71610-044-7071610004470120 TABLET, FILM COATED in 1 BOTTLE (71610-044-70)Marketed from Jul 30, 2020
71610-044-7371610004473135 TABLET, FILM COATED in 1 BOTTLE (71610-044-73)Marketed from Jul 30, 2020
71610-044-8071610004480180 TABLET, FILM COATED in 1 BOTTLE (71610-044-80)Marketed from Mar 23, 2018
71610-044-9271610004492270 TABLET, FILM COATED in 1 BOTTLE (71610-044-92)Marketed from Mar 23, 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 — 600 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203244
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 71610-044_a695e055-6531-4b51-969f-62165d703511SPL ID a695e055-6531-4b51-969f-62165d703511SPL set ID 39149f0e-30ed-4671-8be7-2a484f65d63bRxCUI 310433UNII 6CW7F3G59X
Pharmacologic class
Anti-epileptic Agent

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

N471610004430 followed by a unit qualifier and the quantity

Package 71610-0044-30. 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 203244

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

FDA NDC Directory listings under ANDA 203244
ProductStrengthForm · routeLabelerProduct NDC
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-426
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2141
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2142
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2098
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1007
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1026
GabapentinGabapentin 600 mg/1TabletOralStrides Pharma Science Limited64380-727
GabapentinGabapentin 800 mg/1TabletOralStrides Pharma Science Limited64380-728
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1041
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralDIRECT RX72189-158
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1132
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralProficient Rx LP71205-457
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralProficient Rx LP71205-160
GabapentinGabapentin 800 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1601
GabapentinGabapentin 600 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-066

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