NDC 50436-0201

Provigil

Modafinil

Provigil is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Unit Dose Services. The primary component is Modafinil.

• Product ID: 50436-0201_1e74e36c-9b6e-4d3b-8d7f-1bd56aab2a9a
• NDC: 50436-0201
• Product Type: Human Prescription Drug
• Proprietary Name: Provigil
• Generic Name: Modafinil
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1999-02-15
• Marketing Category: NDA / NDA
• Application Number: NDA020717
• Labeler Name: Unit Dose Services
• Substance Name: MODAFINIL
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 50436-0201-1

30 TABLET in 1 BOTTLE (50436-0201-1)

• Marketing Start Date: 1999-02-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50436-0201-1 [50436020101]

Provigil TABLET

• Marketing Category: NDA
• Application Number: NDA020717
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1999-02-15
• Marketing End Date: 2017-12-31

Drug Details

Active Ingredients

Ingredient	Strength
MODAFINIL	200 mg/1

OpenFDA Data

• SPL SET ID: fd75a8a7-a8ab-4141-9af9-989a220b9c19
• Manufacturer:
  • Unit Dose Services
• UNII:
  • R3UK8X3U3D
• RxNorm Concept Unique ID - RxCUI:
  • 213471
  • 205324

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
21695-234	PROVIGIL	MODAFINIL
21695-235	PROVIGIL	MODAFINIL
35356-372	PROVIGIL	modafinil
50436-0201	Provigil	Provigil
63459-101	Provigil	Provigil
63459-201	Provigil	Provigil
0143-9968	Modafinil	modafinil
0143-9969	Modafinil	modafinil
0378-5573	Modafinil	modafinil
0378-5575	Modafinil	modafinil
0591-3499	Modafinil	Modafinil
0591-3500	Modafinil	Modafinil
0904-6423	Modafinil	Modafinil
0904-6424	Modafinil	Modafinil
0904-6791	Modafinil	modafinil
0904-6792	Modafinil	modafinil
23155-604	Modafinil	Modafinil
23155-605	Modafinil	Modafinil
42043-160	Modafinil	Modafinil
42043-161	Modafinil	Modafinil
42291-599	Modafinil	Modafinil
42291-600	Modafinil	Modafinil
43353-831	Modafinil	modafinil
43353-925	modafinil	modafinil
43353-956	Modafinil	Modafinil
46708-385	Modafinil	Modafinil
46708-386	Modafinil	Modafinil
49884-534	Modafinil	Modafinil