NDC 61919-640

GABAPENTIN

Gabapentin

GABAPENTIN is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Gabapentin.

Product ID61919-640_861db26c-c96c-2177-e053-2991aa0ab04a
NDC61919-640
Product TypeHuman Prescription Drug
Proprietary NameGABAPENTIN
Generic NameGabapentin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-12-30
Marketing CategoryANDA / ANDA
Application NumberANDA090007
Labeler NameDIRECT RX
Substance NameGABAPENTIN
Active Ingredient Strength300 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61919-640-30

30 CAPSULE in 1 BOTTLE (61919-640-30)
Marketing Start Date2019-04-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-640-60 [61919064060]

GABAPENTIN CAPSULE
Marketing CategoryANDA
Application NumberANDA090007
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-08

NDC 61919-640-72 [61919064072]

GABAPENTIN CAPSULE
Marketing CategoryANDA
Application NumberANDA090007
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-08

NDC 61919-640-30 [61919064030]

GABAPENTIN CAPSULE
Marketing CategoryANDA
Application NumberANDA090007
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-09

NDC 61919-640-90 [61919064090]

GABAPENTIN CAPSULE
Marketing CategoryANDA
Application NumberANDA090007
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-19

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN300 mg/1

OpenFDA Data

SPL SET ID:29a70e2d-d3fd-4e32-95dd-7ee721d87388
Manufacturer
UNII

Pharmacological Class

  • Anti-epileptic Agent [EPC]
  • Decreased Central Nervous System Disorganized Electrical Activity [PE]
  • Anti-epileptic Agent [EPC]
  • Decreased Central Nervous System Disorganized Electrical Activity [PE]

NDC Crossover Matching brand name "GABAPENTIN" or generic name "Gabapentin"

NDCBrand NameGeneric Name
0093-4443GabapentinGabapentin
0093-4444GabapentinGabapentin
0143-3991GabapentinGabapentin
0143-3993GabapentinGabapentin
0143-3994GabapentinGabapentin
0143-9992GabapentinGabapentin
0143-9993GabapentinGabapentin
0143-9994GabapentinGabapentin
67877-222GabapentinGabapentin
67877-223GabapentinGabapentin
67877-224GabapentinGabapentin
67877-428GabapentinGabapentin
67877-429GabapentinGabapentin
68001-006GabapentinGabapentin
68001-007GabapentinGabapentin
68071-1212GABAPENTINGABAPENTIN
68071-1292GabapentinGabapentin
68071-1808GABAPENTINGABAPENTIN
68071-1907GABAPENTINGABAPENTIN
68071-1995GabapentinGabapentin
68071-3230GABAPENTINGABAPENTIN
68071-3046GabapentinGabapentin
68071-3244GabapentinGabapentin
68071-4087GabapentinGabapentin
68071-3086GABAPENTINGABAPENTIN
68071-3383GABAPENTINGABAPENTIN
68071-3314GABAPENTINGABAPENTIN
68071-4049GABAPENTINGABAPENTIN
68071-4241GABAPENTINGABAPENTIN
68071-4099GabapentinGabapentin
68071-4113GabapentinGabapentin
68071-4292GabapentinGabapentin
68071-4180GabapentinGabapentin
68071-4090GabapentinGabapentin
68071-4329GabapentinGabapentin
68071-4603GabapentinGabapentin
68071-4169GabapentinGabapentin
68071-4346GabapentinGabapentin
68071-4366GabapentinGabapentin
68071-4729GabapentinGabapentin
68071-4402GABAPENTINGABAPENTIN
68071-4784GABAPENTINGABAPENTIN
68084-774GabapentinGabapentin
68084-783GabapentinGabapentin
68084-797GabapentinGabapentin
68084-762GabapentinGabapentin
0440-5562GABAPENTINGABAPENTIN
0440-5563GABAPENTINGABAPENTIN
68084-802GabapentinGabapentin
68151-1028GabapentinGabapentin
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