EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Product NDC: 68180-287
11-digit product format: 681800287
Labeler code: 68180
Product ID: 68180-287_1b7981ee-8124-46a2-9aab-f9b85d982650
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA204131
Marketing category: ANDA
Marketing start: 2021-06-23
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

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	68180-287	68180-287-06	D	Discontinued by firm		2026-08-11

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 · 12 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB		2021-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204131-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204131-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-06-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204131-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204131-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204131-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204131-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204131-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204131-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204131-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204131-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204131-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204131-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204131-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204131-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204131-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204131-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204131-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204131-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204131-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204131-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204131-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204131-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204131-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204131-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204131-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204131-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204131-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204131-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204131-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204131-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204131-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204131-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204131-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204131-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204131-001	AB	1	`a50c72e98297…`

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
e4fb5710-e23b-429e-9b51-c12366e614fc	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
68180-287-01	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100 in 1 BOTTLE	TABLET, FILM COATED	100		11
68180-287-06	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	30 in 1 BOTTLE	TABLET, FILM COATED	30		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-287-06	EA - Each	68180-287	d8c4aede-8ee3-4d57-99aa-c9d0ff6f437a	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-287	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	11	Current NDC, Legacy NDC, 2 package rows	20231103_e4fb5710-e23b-429e-9b51-c12366e614fc.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	DirectRx	d67e2df4-4094-4f5a-e053-2a95a90ae4aa	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204131 application number: ANDA204131
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Lupin Pharmaceuticals, Inc.	e4fb5710-e23b-429e-9b51-c12366e614fc	2023-11-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204131 application number: ANDA204131 ndc (product): 68180-287

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	e4fb5710-e23b-429e-9b51-c12366e614fc	11
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD	e4fb5710-e23b-429e-9b51-c12366e614fc	11
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	e4fb5710-e23b-429e-9b51-c12366e614fc	11
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	PSN	d67e2df4-4094-4f5a-e053-2a95a90ae4aa	2
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	PSN	f423ab8a-3911-5b3f-e053-2a95a90adb7e	2
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD	d67e2df4-4094-4f5a-e053-2a95a90ae4aa	2
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD	f423ab8a-3911-5b3f-e053-2a95a90adb7e	2
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	d67e2df4-4094-4f5a-e053-2a95a90ae4aa	2
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	f423ab8a-3911-5b3f-e053-2a95a90adb7e	2
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	PSN	868ef2cd-57e7-43f5-8a8d-454e4d0628e5	1
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD	868ef2cd-57e7-43f5-8a8d-454e4d0628e5	1
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	868ef2cd-57e7-43f5-8a8d-454e4d0628e5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-287-01	68180028701	100 TABLET, FILM COATED in 1 BOTTLE (68180-287-01)	2021-06-23	0000-00-00	No	No	Current
68180-287-06	68180028706	30 TABLET, FILM COATED in 1 BOTTLE (68180-287-06)	2021-06-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	DirectRx	2025-01-21	HUMAN PRESCRIPTION DRUG LABEL	2
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Redpharm Drug, Inc. \| LUPIN LIMITED	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	2
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2023-11-02	HUMAN PRESCRIPTION DRUG LABEL	11
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	A-S Medication Solutions	2022-04-28	HUMAN PRESCRIPTION DRUG LABEL	1