NDC 71335-1096

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 ID71335-1096_254f175e-3a2d-4e51-ada4-c861b86ec6a0
NDC71335-1096
Product TypeHuman Prescription Drug
Proprietary NameModafinil
Generic NameModafinil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA202700
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]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71335-1096-1

30 TABLET in 1 BOTTLE (71335-1096-1)
Marketing Start Date2019-02-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1096-2 [71335109602]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA202700
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-13

NDC 71335-1096-4 [71335109604]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA202700
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-13

NDC 71335-1096-3 [71335109603]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA202700
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-13

NDC 71335-1096-6 [71335109606]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA202700
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-13

NDC 71335-1096-7 [71335109607]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA202700
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-13

NDC 71335-1096-5 [71335109605]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA202700
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-13

NDC 71335-1096-1 [71335109601]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA202700
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-13

Drug Details

Active Ingredients

IngredientStrength
MODAFINIL200 mg/1

OpenFDA Data

SPL SET ID:3ead2d94-99ce-4f14-a9df-876eaa8d8882
Manufacturer
UNII

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
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