NDC 0003-1614

BARACLUDE

Entecavir

BARACLUDE is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by E.r. Squibb & Sons, L.l.c.. The primary component is Entecavir.

• Product ID: 0003-1614_0c2fe0fc-58ea-4ca6-8dc6-25f95d4ef74b
• NDC: 0003-1614
• Product Type: Human Prescription Drug
• Proprietary Name: BARACLUDE
• Generic Name: Entecavir
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2005-03-29
• Marketing Category: NDA / NDA
• Application Number: NDA021798
• Labeler Name: E.R. Squibb & Sons, L.L.C.
• Substance Name: ENTECAVIR
• Active Ingredient Strength: 0 mg/mL
• Pharm Classes: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0003-1614-12

1 BOTTLE in 1 CARTON (0003-1614-12) > 210 mL in 1 BOTTLE

• Marketing Start Date: 2005-03-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0003-1614-12 [00003161412]

BARACLUDE SOLUTION

• Marketing Category: NDA
• Application Number: NDA021798
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-03-29

Drug Details

Active Ingredients

Ingredient	Strength
ENTECAVIR	.05 mg/mL

OpenFDA Data

• SPL SET ID: 046e61c9-9298-4b2e-b76e-b26b81fecd20
• Manufacturer:
  • E.R. Squibb & Sons, L.L.C.
• UNII:
  • 5968Y6H45M
• RxNorm Concept Unique ID - RxCUI:
  • 607579
  • 578459
  • 578457
  • 485536
  • 485434
  • 485436

Pharmacological Class

• Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Nucleoside Analog [EXT]
• Nucleoside Reverse Transcriptase Inhibitors [MoA]

NDC Crossover Matching brand name "BARACLUDE" or generic name "Entecavir"

NDC	Brand Name	Generic Name
0003-1611	BARACLUDE	entecavir
0003-1612	BARACLUDE	entecavir
0003-1614	BARACLUDE	entecavir
0093-5786	Entecavir	Entecavir
0093-5787	Entecavir	Entecavir
10135-615	Entecavir	Entecavir
10135-616	Entecavir	Entecavir
16714-717	ENTECAVIR	ENTECAVIR
16714-718	ENTECAVIR	ENTECAVIR
16729-388	Entecavir	Entecavir
16729-389	Entecavir	Entecavir
31722-833	Entecavir	Entecavir
31722-834	Entecavir	Entecavir
42291-261	Entecavir	Entecavir
42291-262	Entecavir	Entecavir