Enpresse

Product NDC: 21695-855
11-digit product format: 216950855
Labeler code: 21695
Product ID: 21695-855_6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levonorgestrel and ethinyl estradiol
Dosage form: KIT
Labeler: Rebel Distributors Corp
Application: ANDA075809
Marketing category: ANDA
Marketing start: 2010-12-20
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-855		I	Inactivated by FDA		2026-10-05
excluded package	package	21695-855	21695-855-01	I	Inactivated by FDA		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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-855-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-855-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-855-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-855-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-855-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-855-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-855-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-855-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-855-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-855-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-855-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-855-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-855-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-855-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-855-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-855-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-855-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-855-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-855-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-855-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-855-01	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-855-01	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075809-001	ENPRESSE-21	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21			2001-07-16
A075809-002	ENPRESSE-28	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB		2001-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075809-002	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 3 · 86 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	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075809-001	ENPRESSE-21	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-21		2001-07-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075809-002	ENPRESSE-28	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET / ORAL-28	AB	2001-07-16	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A075809-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075809-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075809-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075809-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075809-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075809-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075809-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075809-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075809-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075809-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075809-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075809-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075809-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075809-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075809-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075809-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075809-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075809-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075809-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075809-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075809-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075809-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075809-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075809-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075809-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075809-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075809-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075809-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075809-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075809-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075809-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075809-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075809-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075809-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075809-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075809-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075809-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075809-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075809-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075809-002	AB	1	`f41ea6bd6efb…`

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
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11	Product name	4	20250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621f	Product name	1	20250307
8511fc19-172b-4e1f-90ec-2f09c85b16de	Product name	2	20250116
d9a998ac-31a9-4391-9054-c30e50912603	Product name	2	20240829
782f1593-b73e-4d35-8017-647969d714d8	Product name	4	20240805
1a545a57-aed5-4b6e-b1f9-a93c26d50eff	Product name	1	20230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50	Product name	3	20230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689	Product name	5	20230627
0d9f32e2-f85b-4d63-9f04-b06059c34749	Product name	3	20230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5	Product name	3	20210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9	Product name	3	20210513
cec4644c-0fed-4608-a5ea-d3a1b1b6d697	Product name	2	20200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424	Product name	6	20200716
5956a0e2-c373-452c-bdcf-c93d354432ef	Product name	1	20200714
ca306105-d51c-4821-9ec1-8eec753d073d	Product name	1	20200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9	Product name	8	20200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6	Product name	8	20191120
6dd982ab-2966-22ee-3b75-d225abb791aa	Product name	5	20190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4d	Product name	7	20190612
f92411e4-13dd-7baf-106e-9b3fcf758c39	Product name	4	20190502
f713a022-3e1c-4035-bc91-62131bc80b42	Product name	2	20190125
60ff9adc-7870-42ca-8836-514bd9732fa8	Product name	4	20181220
ddff2484-d547-4e6a-bacd-95eef7e31c64	Product name	2	20180807
c6636356-4ccb-40e9-a952-59eb1f2fc859	Product name	4	20180806
79d5025d-8129-440a-b861-6df2d2661609	Product name	3	20180607
e042bc86-5d40-8945-82f8-de9dd95420dd	Product name	6	20180606
d871c48c-6b0b-4203-b55d-72ead21ea7ad	Product name	5	20180419
90854981-3820-4bc4-a1d3-666ec508941c	Product name	2	20180214
390e6d23-3a11-4327-9294-c958a378baae	Product name	4	20180124
12434b90-2738-45d5-9e1b-55001e853273	Product name	2	20171122
b651f154-0364-4007-9dc6-9d33036db1d7	Product name	4	20170808
3395ac9b-f30b-4991-80ba-fd5196be0214	Product name	3	20170802
2d386545-84d1-e1e9-1402-7fc8962353e8	Product name	2	20170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19	Product name	6	20170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8	Product name	4	20170608
00606b81-6e33-4c38-9ca9-bd14bd74d84c	Product name	4	20170501
f4ce24e8-8632-4fad-9984-b693f985f80f	Product name	3	20170501
b17c5419-b38b-579f-10bc-8a4ce69fc044	Product name	5	20170316
120cc5ad-761c-444c-9e82-dec22f96dfe1	Product name	7	20161219
741e98f2-ac6c-4d80-9ca8-c663c171ba1d	Product name	1	20161121
01996782-abcb-4e6d-bcaf-4a23e6a95c0c	Product name	1	20160714
2aecf0b6-88a0-49e5-92e1-983c700c116c	Product name	1	20151222
61972742-5d4d-491d-a881-b6bc3a011577	Product name	1	20151113
cc765024-f257-4c67-b780-c356aadd6980	Product name	3	20150902
5e13e814-349e-3480-99f3-ee22a591426f	Product name	2	20150518
5a9b579b-8431-5b3a-2ba4-86556704f873	Product name	1	20140508
5f44c957-835a-ada0-662f-5b1071b7a68b	Product name	1	20140508
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508
d03a75af-b11b-673b-268b-318050d0b3bd	Product name	1	20140508
d0cc7d42-77a7-b452-c6c3-a162fa11225f	Product name	1	20140508
e5ccd419-1745-560a-1e25-c6e3941c710a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-855-01	2019-09-24	C162847	48780-1	934fe258-48ae-48b1-e053-8cdaa90a720a	ENPRESSE™ – 28 TABLETS (levonorgestrel and ethinyl estradiol tablets, USP – triphasic regimen)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-855-01	Enpresse	6 in 1 CARTON	KIT	6		1
21695-855-01	Enpresse	1 in 1 POUCH	KIT	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-855-01	EA - Each	21695-855	7e7aa468-3287-4d2b-8980-4118587624d6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETHINYL ESTRADIOL	ACTIVE INGREDIENT	423D2T571U	ENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]	1
LEVONORGESTREL	ACTIVE INGREDIENT	5W7SIA7YZW	ENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]	1
ETHINYL ESTRADIOL	ACTIVE MOIETY	423D2T571U	ENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]	1
LEVONORGESTREL	ACTIVE MOIETY	5W7SIA7YZW	ENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	ENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]	1
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	ENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-855	ENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20110622_6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
761977	{6 (ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet) / 10 (ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet) / 5 (ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Enpresse 28 Day]	BPCK	6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8	1
748832	{6 (ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet) / 10 (ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet) / 5 (ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack	GPCK	6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8	1
761977	Enpresse 28 Day Triphasic Pack	PSN	6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8	1
748832	Eth estra-Levonorgest 0.03-0.05 MG (6) Oral Tablet / Eth estra-Levonorgest 0.03-0.125 MG (10) Oral Tablet / Eth estra-Levonorgest 0.04-0.075 MG (5) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack	PSN	6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8	1
310230	ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet	PSN	6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8	1
348804	ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet	PSN	6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8	1
348805	ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet	PSN	6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8	1
748797	inert 1 MG Oral Tablet	PSN	6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8	1
310230	ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet	SCD	6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8	1
348804	ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet	SCD	6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8	1
348805	ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet	SCD	6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8	1
748797	inert ingredients 1 MG Oral Tablet	SCD	6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8	1
761977	Enpresse 28 Day Pack	SY	6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8	1
348804	ethinyl estradiol 30 MCG / levonorgestrel 125 MCG Oral Tablet	SY	6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8	1
348805	ethinyl estradiol 40 MCG / levonorgestrel 75 MCG Oral Tablet	SY	6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-855-01	21695085501	6 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ENPRESSE™ – 28 TABLETS (levonorgestrel and ethinyl estradiol tablets, USP – triphasic regimen)	Rebel Distributors Corp	2011-01-26	HUMAN PRESCRIPTION DRUG LABEL	1