emtricitabine and tenofovir disoproxil fumarate
Generic: emtricitabine and tenofovir disoproxil fumarate
Labeler: zydus pharmaceuticals usa inc.Drug Facts
Product Profile
Brand Name
emtricitabine and tenofovir disoproxil fumarate
Generic Name
emtricitabine and tenofovir disoproxil fumarate
Labeler
zydus pharmaceuticals usa inc.
Dosage Form
TABLET, FILM COATED
Routes
Active Ingredients
emtricitabine 133 mg/1, tenofovir disoproxil fumarate 200 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
70710-1365
Product ID
70710-1365_919c0aaa-f6d2-426d-a673-ef5c806f9a3a
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA212689
Listing Expiration
2026-12-31
Marketing Start
2021-07-01
Pharmacologic Class
Established (EPC)
Mechanism of Action
Chemical Structure
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
707101365
Hyphenated Format
70710-1365
Supplemental Identifiers
RxCUI
UNII
NUI
Packaging Origin
Original Packager
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
emtricitabine and tenofovir disoproxil fumarate (source: ndc)
Generic Name
emtricitabine and tenofovir disoproxil fumarate (source: ndc)
Application Number
ANDA212689 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 133 mg/1
- 200 mg/1
Packaging
- 30 TABLET, FILM COATED in 1 BOTTLE (70710-1365-3)
- 10 BLISTER PACK in 1 CARTON (70710-1365-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1365-2)
- 90 TABLET, FILM COATED in 1 BOTTLE (70710-1365-9)
Packages (3)
Ingredients (2)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
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