Prempro

Product NDC: 50090-0573
11-digit product format: 500900573
Labeler code: 50090
Product ID: 50090-0573_cfa25293-cd41-4b70-b78b-240b9172a631
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: conjugated estrogens and medroxyprogesterone acetate
Dosage form: TABLET, SUGAR COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA020527
Marketing category: NDA
Marketing start: 2009-09-21
Marketing end: 0000-00-00
Substance: ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
Active strength: 1 mg/1; mg/1
Pharmacologic classes: Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS],Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	50090-0573		I	Inactivated by FDA		2026-08-11
excluded package	package	50090-0573	50090-0573-0	I	Inactivated by FDA		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 · 30 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	50090-0573-0	`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	50090-0573-0	`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	50090-0573-0	`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	50090-0573-0	`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	50090-0573-0	`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	50090-0573-0	`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	50090-0573-0	`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	50090-0573-0	`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	50090-0573-0	`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	50090-0573-0	`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	50090-0573-0	`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	50090-0573-0	`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	50090-0573-0	`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	50090-0573-0	`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	50090-0573-0	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020527-001	PREMPRO	ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17
N020527-002	PREMPHASE 14/14	ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17
N020527-003	PREMPRO	ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09
N020527-004	PREMPRO	ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12
N020527-005	PREMPRO	ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04

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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020527-001	PREMPRO	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020527-002	PREMPHASE 14/14	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020527-003	PREMPRO	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020527-004	PREMPRO	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020527-005	PREMPRO	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020527-001	PREMPRO	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020527-002	PREMPHASE 14/14	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020527-003	PREMPRO	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020527-004	PREMPRO	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020527-005	PREMPRO	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020527-001	PREMPRO	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020527-002	PREMPHASE 14/14	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020527-003	PREMPRO	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020527-004	PREMPRO	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020527-005	PREMPRO	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020527-001	PREMPRO	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020527-002	PREMPHASE 14/14	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020527-003	PREMPRO	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020527-004	PREMPRO	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020527-005	PREMPRO	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020527-001	PREMPRO	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020527-002	PREMPHASE 14/14	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020527-003	PREMPRO	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020527-004	PREMPRO	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020527-005	PREMPRO	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020527-001	PREMPRO	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020527-002	PREMPHASE 14/14	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020527-003	PREMPRO	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020527-004	PREMPRO	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020527-005	PREMPRO	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020527-001	PREMPRO	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020527-002	PREMPHASE 14/14	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020527-003	PREMPRO	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020527-004	PREMPRO	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020527-005	PREMPRO	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020527-001	PREMPRO	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020527-002	PREMPHASE 14/14	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020527-003	PREMPRO	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020527-004	PREMPRO	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020527-005	PREMPRO	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04	`5bbf6a4d5a75…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dce	Product name	6	20240606
d95be220-b30e-4165-a12d-f83825b0efb1	Product name	1	20160111
882e78d5-69f7-4a43-812f-1c1628241bbc	Product name	1	20150910
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2	Product name	1	20140508
2e1ce74f-4938-37b4-e2b4-cfd7971b45ea	Product name	1	20140508
51a98800-9a04-9e42-2219-e588f17f9e48	Product name	1	20140508
d90784c3-64a2-2f23-9acd-d948d25bf235	Product name	1	20140508
f363ed61-d8ad-8f59-ee92-52a12578e008	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-0573-0	2023-01-30	C162847	48780-1	9d75b9d1-00cf-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use PREMPRO/PREMPHASE safely and effectively. See full prescribing information for PREMPRO/PREMPHASE. PREMPRO ® (conjugated estrogens/medroxyprogesterone acetate tablets) PREMPHASE ® (conjugated estrogens plus medroxyprogesterone acetate tablets) Initial U.S. Approval: 1995
50090-0573-0	2020-02-12	C162847	48780-1	9d75b9d1-00cf-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use PREMPRO/PREMPHASE safely and effectively. See full prescribing information for PREMPRO/PREMPHASE. PREMPRO ® (conjugated estrogens/medroxyprogesterone acetate tablets) PREMPHASE ® (conjugated estrogens plus medroxyprogesterone acetate tablets) Initial U.S. Approval: 1995
50090-0573-0	2020-01-31	C162847	48780-1	9d75b9d1-00cf-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use PREMPRO/PREMPHASE safely and effectively. See full prescribing information for PREMPRO/PREMPHASE. PREMPRO ® (conjugated estrogens/medroxyprogesterone acetate tablets) PREMPHASE ® (conjugated estrogens plus medroxyprogesterone acetate tablets) Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-0573-0	Prempro	1 in 1 CARTON	TABLET, SUGAR COATED	1		21
50090-0573-0	Prempro	28 in 1 BLISTER PACK	TABLET, SUGAR COATED	28		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0573-0	EA - Each	50090-0573	e910f444-6753-4b6e-b438-3d47b79fe268	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0573	PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [A-S MEDICATION SOLUTIONS]	21	Legacy NDC, 2 package rows	20210206_3aff3442-641c-4639-8273-cf0347d8e4c8.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
Prempro	CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	fd0c0836-5d23-2183-da81-9dc7f4287052	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020527 application number: NDA020527

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IU5QR144QX	ESTROGENS, CONJUGATED	12126-59-9	ESTROGENS, CONJUGATED
C2QI4IOI2G	MEDROXYPROGESTERONE ACETATE	71-58-9	MEDROXYPROGESTERONE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000499	{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet) } Pack [Prempro 0.625/2.5 28 Day]	BPCK	3aff3442-641c-4639-8273-cf0347d8e4c8	21
1000395	{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet) } Pack	GPCK	3aff3442-641c-4639-8273-cf0347d8e4c8	21
1000395	Estrogens Conj-Medroxyprogest Ac 0.625-2.5 MG (28) Oral Tablet 28 Day Pack	PSN	3aff3442-641c-4639-8273-cf0347d8e4c8	21
1000355	estrogens, conjugated 0.625 MG / medroxyPROGESTERone acetate 2.5 MG Oral Tablet	PSN	3aff3442-641c-4639-8273-cf0347d8e4c8	21
1000499	PREMPRO 0.625/2.5 28 Day Pack	PSN	3aff3442-641c-4639-8273-cf0347d8e4c8	21
1000355	estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet	SCD	3aff3442-641c-4639-8273-cf0347d8e4c8	21
1000499	Prempro 0.625/2.5 28 Day Pack	SY	3aff3442-641c-4639-8273-cf0347d8e4c8	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0573-0	50090057300	1 BLISTER PACK in 1 CARTON (50090-0573-0) > 28 TABLET, SUGAR COATED in 1 BLISTER PACK	1 blister pack	2017-01-01	0000-00-00	No	No	Current