Home NDC 64380-719 Emtricitabine and Tenofovir Disoproxil Fumarate
Product NDC 64380-719
11-digit product format 643800719
Labeler code 64380
Product ID 64380-719_bf6c27ef-5fde-4c9f-82b2-fbf0797bd359
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name EMTRICITABINE and TENOFOVIR Disoproxil Fumarate
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA091055
Marketing category ANDA
Marketing start 2021-03-30
Substance EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength 200; 300 mg/1; mg/1
Pharmacologic classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091055-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A091055-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-01-13 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Emtricitabine and Tenofovir Disoproxil Fumarate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EMTRICITABINE 200 mg/1 TENOFOVIR DISOPROXIL FUMARATE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G70B4ETF4S Internal UNII lookup OTT9J7900I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 476556 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64380-719-04 Emtricitabine and Tenofovir Disoproxil Fumarate 30 in 1 BOTTLE, PLASTIC TABLET 30 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-719 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET [STRIDES PHARMA SCIENCE LIMITED] 9 Current NDC, Legacy NDC, 1 package rows 20240926_bc37cba9-83c8-4660-a527-cd77fae9ea87.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64380-719-04 64380071904 30 TABLET in 1 BOTTLE, PLASTIC (64380-719-04) 30 tablet 2021-03-30 0000-00-00 No No Current