NDC 69097-233

nevirapine

Nevirapine

nevirapine is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Nevirapine Hemihydrate.

• Product ID: 69097-233_d8c3e274-100e-4526-84a2-ef541b415d4e
• NDC: 69097-233
• Product Type: Human Prescription Drug
• Proprietary Name: nevirapine
• Generic Name: Nevirapine
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2017-08-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207684
• Labeler Name: Cipla USA Inc.
• Substance Name: NEVIRAPINE HEMIHYDRATE
• Active Ingredient Strength: 50 mg/5mL
• Pharm Classes: Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69097-233-44

100 mL in 1 BOTTLE (69097-233-44)

• Marketing Start Date: 2017-08-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69097-233-44 [69097023344]

nevirapine SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA207684
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-03
• Inactivation Date: 2020-01-31

NDC 69097-233-46 [69097023346]

nevirapine SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA207684
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-03
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
NEVIRAPINE HEMIHYDRATE	50 mg/5mL

OpenFDA Data

• SPL SET ID: d1e92221-5e02-4ed9-b53e-d83bbbd07944
• Manufacturer:
  • Cipla USA Inc.
• UNII:
  • B7XF2TD73C
• RxNorm Concept Unique ID - RxCUI:
  • 311943

Pharmacological Class

• Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Non-Nucleoside Analog [EXT]
• Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
• Cytochrome P450 3A Inducers [MoA]
• Cytochrome P450 2B6 Inducers [MoA]

NDC Crossover Matching brand name "nevirapine" or generic name "Nevirapine"

NDC	Brand Name	Generic Name
0378-4050	Nevirapine	nevirapine
0378-4890	Nevirapine	nevirapine
0378-6950	Nevirapine	nevirapine
0781-5893	Nevirapine	Nevirapine
31722-505	Nevirapine	Nevirapine
33342-004	Nevirapine	Nevirapine
33342-238	NEVIRAPINE	NEVIRAPINE
42571-131	NEVIRAPINE	NEVIRAPINE
51991-331	Nevirapine	NEVIRAPINE
53104-0166	nevirapine	nevirapine
53808-0680	Nevirapine	nevirapine
53808-1069	nevirapine	nevirapine
61442-470	Nevirapine	Nevirapine
64380-709	Nevirapine	Nevirapine
65162-209	Nevirapine	Nevirapine
69097-403	NEVIRAPINE	NEVIRAPINE
69097-233	nevirapine	nevirapine
65862-057	Nevirapine	Nevirapine
65862-027	Nevirapine	Nevirapine
65862-932	NEVIRAPINE	NEVIRAPINE
65862-933	NEVIRAPINE	NEVIRAPINE
47781-317	Nevirapine Extended Release	nevirapine
0597-0046	Viramune	nevirapine
0597-0047	Viramune	nevirapine
0597-0123	Viramune	nevirapine
53808-0808	Viramune	nevirapine