Home NDC 59651-166 Emtricitabine and Tenofovir Disoproxil Fumarate
Product NDC 59651-166
11-digit product format 596510166
Labeler code 59651
Product ID 59651-166_a805c27a-1154-4aac-9af8-bbd755be027f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Emtricitabine and Tenofovir Disoproxil Fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA211640
Marketing category ANDA
Marketing start 2023-03-09
Substance EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength 133; 200 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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211640-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET / ORAL AB 2023-03-09 A211640-002 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET / ORAL AB 2023-03-09 A211640-003 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET / ORAL AB 2023-03-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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.
Product history page 1 of 2 · 75 observed 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 2026-09-14 22:38:34 2026-08 A211640-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET / ORAL AB 2023-03-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211640-002 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET / ORAL AB 2023-03-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211640-003 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET / ORAL AB 2023-03-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211640-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET / ORAL AB 2023-03-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211640-002 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET / ORAL AB 2023-03-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211640-003 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET / ORAL AB 2023-03-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211640-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET / ORAL AB 2023-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211640-002 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET / ORAL AB 2023-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211640-003 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET / ORAL AB 2023-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211640-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET / ORAL AB 2023-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211640-002 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET / ORAL AB 2023-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211640-003 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET / ORAL AB 2023-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211640-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET / ORAL AB 2023-03-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211640-002 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET / ORAL AB 2023-03-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211640-003 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET / ORAL AB 2023-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211640-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET / ORAL AB 2023-03-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211640-002 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET / ORAL AB 2023-03-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211640-003 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET / ORAL AB 2023-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211640-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET / ORAL AB 2023-03-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211640-002 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET / ORAL AB 2023-03-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211640-003 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET / ORAL AB 2023-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211640-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET / ORAL AB 2023-03-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211640-002 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET / ORAL AB 2023-03-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211640-003 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET / ORAL AB 2023-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211640-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET / ORAL AB 2023-03-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211640-002 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET / ORAL AB 2023-03-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211640-003 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET / ORAL AB 2023-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211640-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET / ORAL AB 2023-03-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211640-002 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET / ORAL AB 2023-03-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211640-003 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET / ORAL AB 2023-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211640-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET / ORAL AB 2023-03-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211640-002 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET / ORAL AB 2023-03-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211640-003 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET / ORAL AB 2023-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211640-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET / ORAL AB 2023-03-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211640-002 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET / ORAL AB 2023-03-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211640-003 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET / ORAL AB 2023-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211640-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET / ORAL AB 2023-03-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211640-002 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET / ORAL AB 2023-03-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211640-003 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET / ORAL AB 2023-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211640-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET / ORAL AB 2023-03-09 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Emtricitabine and Tenofovir Disoproxil Fumarate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EMTRICITABINE 133 mg/1 TENOFOVIR DISOPROXIL FUMARATE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination OTT9J7900I Internal UNII lookup G70B4ETF4S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1744001 Internal RxNorm lookup 1744005 Internal RxNorm lookup 1744009 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 59651-166-30 Emtricitabine and Tenofovir Disoproxil Fumarate 30 in 1 BOTTLE TABLET, FILM COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-166 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 Current NDC, 1 package rows 20240109_974d2ec8-1b51-4e69-991d-0d5dea8360f4.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 59651-166-30 59651016630 30 TABLET, FILM COATED in 1 BOTTLE (59651-166-30) 2023-03-09 No No Current