NDC 21695-234

PROVIGIL

Modafinil

PROVIGIL is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Modafinil.

• Product ID: 21695-234_8b79d52e-e6e5-4aaf-8835-242c72d6ee38
• NDC: 21695-234
• Product Type: Human Prescription Drug
• Proprietary Name: PROVIGIL
• Generic Name: Modafinil
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2005-06-03
• Marketing Category: NDA / NDA
• Application Number: NDA020717
• Labeler Name: Rebel Distributors Corp
• Substance Name: MODAFINIL
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]
• DEA Schedule: CIV
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-234-30

30 TABLET in 1 BOTTLE (21695-234-30)

• Marketing Start Date: 2005-06-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-234-15 [21695023415]

PROVIGIL TABLET

• Marketing Category: NDA
• Application Number: NDA020717
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-06-03
• Inactivation Date: 2019-09-24

NDC 21695-234-30 [21695023430]

PROVIGIL TABLET

• Marketing Category: NDA
• Application Number: NDA020717
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-06-03
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
MODAFINIL	100 mg/1

OpenFDA Data

• SPL SET ID: 8b79d52e-e6e5-4aaf-8835-242c72d6ee38
• Manufacturer:
  • Rebel Distributors Corp
• UNII:
  • R3UK8X3U3D
• RxNorm Concept Unique ID - RxCUI:
  • 213471
  • 205324
  • 260218
  • 226426

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