entecavir

Generic: entecavir anhydrous

Labeler: cameron pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entecavir
Generic Name entecavir anhydrous
Labeler cameron pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

entecavir anhydrous .5 mg/1

Manufacturer
Cameron Pharmaceuticals

Identifiers & Regulatory

Product NDC 42494-457
Product ID 42494-457_3ada45bd-97aa-4713-ad29-6e462668c108
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216857
Listing Expiration 2026-12-31
Marketing Start 2025-05-15

Pharmacologic Class

Established (EPC)
hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
nucleoside reverse transcriptase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42494457
Hyphenated Format 42494-457

Supplemental Identifiers

RxCUI
485434 485436
UPC
0342494457305 0342494458302
UNII
NNU2O4609D
NUI
N0000175656 N0000175459 N0000009947

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name entecavir (source: ndc)
Generic Name entecavir anhydrous (source: ndc)
Application Number ANDA216857 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (42494-457-30)
source: ndc

Packages (1)

42494-457-30 30 TABLET in 1 BOTTLE (42494-457-30)

Ingredients (1)

entecavir anhydrous (.5 mg/1)

Linked Drug Pages (1)

ENTECAVIR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3ada45bd-97aa-4713-ad29-6e462668c108", "openfda": {"nui": ["N0000175656", "N0000175459", "N0000009947"], "upc": ["0342494457305", "0342494458302"], "unii": ["NNU2O4609D"], "rxcui": ["485434", "485436"], "spl_set_id": ["92a5bebd-6408-463d-933c-bab8338a677e"], "pharm_class_epc": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Cameron Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (42494-457-30)", "package_ndc": "42494-457-30", "marketing_start_date": "20250515"}], "brand_name": "ENTECAVIR", "product_id": "42494-457_3ada45bd-97aa-4713-ad29-6e462668c108", "dosage_form": "TABLET", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Analog [EXT]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "42494-457", "generic_name": "ENTECAVIR ANHYDROUS", "labeler_name": "Cameron Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ENTECAVIR", "active_ingredients": [{"name": "ENTECAVIR ANHYDROUS", "strength": ".5 mg/1"}], "application_number": "ANDA216857", "marketing_category": "ANDA", "marketing_start_date": "20250515", "listing_expiration_date": "20261231"}