Emtricitabine

Product NDC: 65862-301
Requested package NDC: 65862-301-26
11-digit product format: 658620301
Labeler code: 65862
Product ID: 65862-301_b4553ee9-214c-43d5-b704-16f4eee5f2b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Emtricitabine
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA079188
Marketing category: ANDA
Marketing start: 2023-03-15
Substance: EMTRICITABINE
Active strength: 200 mg/1
Pharmacologic classes: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], 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
unfinished package	package	65862-301	65862-301-26	UNFINISHED	Active or certified unfinished drug listing		2026-08-17

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 · 14 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`

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
A079188-001	EMTRICITABINE	EMTRICITABINE	200MG	CAPSULE / ORAL	AB		2023-03-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079188-001	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
2026-08-18 06:07:40	2026-07	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A079188-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079188-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079188-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079188-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079188-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079188-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079188-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079188-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079188-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079188-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079188-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079188-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079188-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079188-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079188-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079188-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079188-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079188-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079188-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079188-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079188-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079188-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079188-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A079188-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Emtricitabine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EMTRICITABINE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G70B4ETF4S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
403875	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
cdfb7868-3eba-46e1-a286-ca40760fd98d	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
dc21b1c2-b0f7-7f56-b95f-dcd93cbc30a4	Product name	3	20240320
c0c98dbe-5e23-74e9-f9fc-07af05f77d95	Product name	8	20240319
1cd1fd33-94db-4c45-bd26-82773ea350a3	Product name	2	20220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690f	Product name	4	20220314
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
65862-301-05	Emtricitabine	500 in 1 BOTTLE	CAPSULE	500		2
65862-301-30	Emtricitabine	30 in 1 BOTTLE	CAPSULE	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-301-30	EA - Each	65862-301	0419de9d-c826-4683-b98e-4f66aa4a2597	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-301	EMTRICITABINE CAPSULE [AUROBINDO PHARMA LIMITED]	2	Current NDC, 2 package rows	20240209_cdfb7868-3eba-46e1-a286-ca40760fd98d.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Emtricitabine	EMTRICITABINE	Aurobindo Pharma Limited	cdfb7868-3eba-46e1-a286-ca40760fd98d	2024-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079188 application number: ANDA079188 ndc (product): 65862-301

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G70B4ETF4S	EMTRICITABINE	143491-57-0	EMTRICITABINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
403875	emtricitabine 200 MG Oral Capsule	PSN	cdfb7868-3eba-46e1-a286-ca40760fd98d	2
403875	emtricitabine 200 MG Oral Capsule	SCD	cdfb7868-3eba-46e1-a286-ca40760fd98d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
65862-301-26	65862030126	2500 CAPSULE in 1 BAG (65862-301-26)	2500 capsule	15-MAR-23	Current