EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Product NDC: 69097-741
Requested package NDC: 69097-741-02
11-digit product format: 690970741
Labeler code: 69097
Product ID: 69097-741_07c79c8d-b3e7-442b-8a53-ad5dc71f28a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA090958
Marketing category: ANDA
Marketing start: 2021-11-01
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: 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL			2021-04-02

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090958-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090958-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090958-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A090958-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090958-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090958-001	AB	1	`87673890dc5c…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090958-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090958-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090958-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090958-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090958-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090958-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090958-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090958-001	AB	1	`cb3db0bc1861…`

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	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d08c9455-e788-435c-9076-2bdb1a4f5b37	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
33cd1557-9629-1a35-1f2f-499cf7c608bc	Product name	2	20260305
5f93de8c-a439-4aaa-862f-7cf2524cb240	Product name	3	20250812
6286e356-28a5-4b4b-a174-76bf53b211e3	Product name	6	20250121
233e3f87-da6c-4b7d-80cb-963ca3258270	Product name	2	20240419
dc21b1c2-b0f7-7f56-b95f-dcd93cbc30a4	Product name	3	20240320
c0c98dbe-5e23-74e9-f9fc-07af05f77d95	Product name	8	20240319
4ef90d80-1289-4267-a2bb-01c741d1208f	Product name	1	20230829
72dcca4e-6eae-4149-a92b-264c2a07004f	Product name	1	20230808
1cd1fd33-94db-4c45-bd26-82773ea350a3	Product name	2	20220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690f	Product name	4	20220314
320f244d-8b4e-4893-9f14-104b2a8e0aaf	Product name	2	20201007
7ff71f22-5b66-4a3d-bf64-671893a6409d	Product name	2	20201007
6f122144-2ceb-48fa-a906-0d2eb742717e	Product name	1	20190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67	Product name	1	20181211
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7	Product name	1	20180911
d1784558-3c5f-4d73-8a7c-051102bb6c92	Product name	1	20160405
7fd46899-3505-4ed4-b856-6b2509a76004	Product name	1	20151123
0583b5e6-2e6e-c94b-9ff6-81a81ba199de	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69097-741-02	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-741-02	EA - Each	69097-741	3bfda7ef-1c83-40e8-9e4a-e472752367d6	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-741	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [CIPLA USA INC.]	4	Current NDC, Legacy NDC, 1 package rows	20250104_d08c9455-e788-435c-9076-2bdb1a4f5b37.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Cipla USA Inc.	d08c9455-e788-435c-9076-2bdb1a4f5b37	2024-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090958 application number: ANDA090958 ndc (package): 69097-741-02 ndc (product): 69097-741 ndc11 (package): 69097074102
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Exelan Pharmaceuticals, Inc.	31af598d-6ef2-469b-ac4c-3ac805e6fa44	2021-04-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090958 application number: ANDA090958
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Cipla USA Inc.	1ac2a796-495e-4182-8eec-40363d8a85c0	2021-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090958 application number: ANDA090958

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G70B4ETF4S	EMTRICITABINE	143491-57-0	EMTRICITABINE
OTT9J7900I	TENOFOVIR DISOPROXIL FUMARATE	202138-50-9	TENOFOVIR DISOPROXIL FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	PSN	d08c9455-e788-435c-9076-2bdb1a4f5b37	4
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD	d08c9455-e788-435c-9076-2bdb1a4f5b37	4
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	d08c9455-e788-435c-9076-2bdb1a4f5b37	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-741-02	69097074102	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-741-02)	2021-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Cipla USA Inc. \| CIPLA LIMITED KURKUMBH \| APPCO PHARMA LLC	2024-12-05	HUMAN PRESCRIPTION DRUG LABEL	4