NDC 71335-1402

Modafinil

Modafinil

Modafinil is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Modafinil.

Product ID71335-1402_16c54b43-47fc-4abb-99e1-a3285f59382d
NDC71335-1402
Product TypeHuman Prescription Drug
Proprietary NameModafinil
Generic NameModafinil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-08-01
Marketing CategoryANDA / ANDA
Application NumberANDA078963
Labeler NameBryant Ranch Prepack
Substance NameMODAFINIL
Active Ingredient Strength200 mg/1
Pharm ClassesCentral Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71335-1402-1

30 TABLET in 1 BOTTLE (71335-1402-1)
Marketing Start Date2019-11-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1402-4 [71335140204]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA078963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-18

NDC 71335-1402-7 [71335140207]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA078963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-18

NDC 71335-1402-2 [71335140202]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA078963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-18

NDC 71335-1402-6 [71335140206]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA078963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-18

NDC 71335-1402-5 [71335140205]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA078963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-18

NDC 71335-1402-3 [71335140203]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA078963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-18

NDC 71335-1402-1 [71335140201]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA078963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-18

Drug Details

Active Ingredients

IngredientStrength
MODAFINIL200 mg/1

Pharmacological Class

  • Central Nervous System Stimulation [PE]
  • Increased Sympathetic Activity [PE]
  • Sympathomimetic-like Agent [EPC]

NDC Crossover Matching brand name "Modafinil" or generic name "Modafinil"

NDCBrand NameGeneric Name
0143-9968Modafinilmodafinil
0143-9969Modafinilmodafinil
0378-5573Modafinilmodafinil
0378-5575Modafinilmodafinil
0591-3499ModafinilModafinil
0591-3500ModafinilModafinil
0904-6423ModafinilModafinil
0904-6424ModafinilModafinil
0904-6791Modafinilmodafinil
0904-6792Modafinilmodafinil
23155-604ModafinilModafinil
23155-605ModafinilModafinil
42043-160ModafinilModafinil
42043-161ModafinilModafinil
42291-599ModafinilModafinil
42291-600ModafinilModafinil
43353-831Modafinilmodafinil
43353-925modafinilmodafinil
43353-956ModafinilModafinil
46708-385ModafinilModafinil
46708-386ModafinilModafinil
49884-534ModafinilModafinil
68084-721ModafinilModafinil
68084-621ModafinilModafinil
68258-7981modafinilmodafinil
68788-7408ModafinilModafinil
70710-1073ModafinilModafinil
70710-1072ModafinilModafinil
70771-1051ModafinilModafinil
70771-1052ModafinilModafinil
71335-0259ModafinilModafinil
71335-0811ModafinilModafinil
71335-0997ModafinilModafinil
72578-005ModafinilModafinil
72578-006ModafinilModafinil
49884-535ModafinilModafinil
50090-2472ModafinilModafinil
50090-2473ModafinilModafinil
50090-3865ModafinilModafinil
50268-570ModafinilModafinil
50090-4144ModafinilModafinil
50268-571ModafinilModafinil
50742-153ModafinilModafinil
50742-152ModafinilModafinil
51079-561ModafinilModafinil
51079-562ModafinilModafinil
55253-801ModafinilModafinil
55253-802ModafinilModafinil
55700-695ModafinilModafinil
55700-688ModafinilModafinil

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.