Emtricitabine and Tenofovir Disoproxil Fumarate

Product NDC: 69238-1527
Requested package NDC: 69238-1527-3
11-digit product format: 692381527
Labeler code: 69238
Product ID: 69238-1527_16159b02-5612-480f-9089-a60870d60768
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Emtricitabine and Tenofovir Disoproxil Fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA209721
Marketing category: ANDA
Marketing start: 2018-08-26
Marketing end: 0000-00-00
Substance: EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength: 200 mg/1; mg/1
Pharmacologic classes: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69238-1527	69238-1527-3	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209721-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2018-08-22
A209721-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2018-08-22
A209721-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2018-08-22
A209721-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-08-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A209721-001	AB
A209721-002	AB
A209721-003	AB
A209721-004	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.

Product history page 1 of 5 · 172 observed 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	A209721-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2018-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209721-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2018-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209721-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2018-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209721-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-08-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209721-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2018-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209721-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2018-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209721-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2018-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209721-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209721-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2018-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209721-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2018-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209721-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2018-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209721-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209721-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2018-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209721-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2018-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209721-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2018-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209721-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209721-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2018-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209721-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2018-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209721-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2018-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209721-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209721-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2018-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209721-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2018-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209721-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2018-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209721-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209721-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2018-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209721-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2018-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209721-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2018-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209721-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209721-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2018-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209721-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2018-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209721-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2018-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209721-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209721-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2018-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209721-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2018-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209721-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2018-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209721-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209721-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2018-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209721-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2018-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209721-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2018-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209721-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-08-22	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 150 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209721-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209721-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209721-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209721-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209721-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209721-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209721-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209721-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209721-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209721-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209721-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209721-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209721-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209721-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209721-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209721-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209721-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209721-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209721-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209721-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209721-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209721-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209721-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209721-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209721-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209721-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209721-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209721-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209721-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209721-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209721-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209721-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209721-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209721-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209721-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209721-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209721-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209721-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209721-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209721-004	AB	1	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A209721-001	PC	2021-03-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209721-002	PC	2021-03-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209721-003	PC	2021-03-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209721-001	PC	2021-03-09	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209721-002	PC	2021-03-09	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209721-003	PC	2021-03-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209721-001	PC	2021-03-09	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209721-002	PC	2021-03-09	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209721-003	PC	2021-03-09	`5aa47cf7b7d7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69238-1527-3	2024-01-30	C162847	48780-1	1030e365-3670-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS safely and effectively. See full prescribing information for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS. EMTRICITABINE and TENOFOVIR DISOPROXIL FUMARATE tablets, for oral use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69238-1527-3	Emtricitabine and Tenofovir Disoproxil Fumarate	30 in 1 BOTTLE	TABLET, FILM COATED	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1527	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]	3	Legacy NDC, 1 package rows	20200730_70b3deb4-951d-4d9b-a811-be5fa05529a9.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 · 2 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	Amneal Pharmaceuticals NY LLC	94d78028-4ba5-4a5d-bd6f-5eca2a1b4b9d	2021-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209721 application number: ANDA209721
Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Amneal Pharmaceuticals NY LLC	b0459301-2bff-4336-9172-b90c7a582433	2020-11-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209721 application number: ANDA209721

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
1744001	emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral Tablet	PSN	70b3deb4-951d-4d9b-a811-be5fa05529a9	3
1744005	emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG Oral Tablet	PSN	70b3deb4-951d-4d9b-a811-be5fa05529a9	3
1744009	emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG Oral Tablet	PSN	70b3deb4-951d-4d9b-a811-be5fa05529a9	3
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	PSN	70b3deb4-951d-4d9b-a811-be5fa05529a9	3
1744001	emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral Tablet	SCD	70b3deb4-951d-4d9b-a811-be5fa05529a9	3
1744005	emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG Oral Tablet	SCD	70b3deb4-951d-4d9b-a811-be5fa05529a9	3
1744009	emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG Oral Tablet	SCD	70b3deb4-951d-4d9b-a811-be5fa05529a9	3
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD	70b3deb4-951d-4d9b-a811-be5fa05529a9	3
1744001	emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG) Oral Tablet	SY	70b3deb4-951d-4d9b-a811-be5fa05529a9	3
1744005	emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG (equivalent to tenofovir disoproxil 163 MG) Oral Tablet	SY	70b3deb4-951d-4d9b-a811-be5fa05529a9	3
1744009	emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG (equivalent to tenofovir disoproxil 204 MG) Oral Tablet	SY	70b3deb4-951d-4d9b-a811-be5fa05529a9	3
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	70b3deb4-951d-4d9b-a811-be5fa05529a9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1527-3	69238152703	30 TABLET, FILM COATED in 1 BOTTLE (69238-1527-3)	2018-08-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Emtricitabine and Tenofovir Disoproxil Fumarate	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals Private Limited Oral Solid Dosage Unit	2020-07-20	HUMAN PRESCRIPTION DRUG LABEL	3