Medroxyprogesterone Acetate

Product NDC: 53002-3570
11-digit product format: 530023570
Labeler code: 53002
Product ID: 53002-3570_ee170f0d-4dd7-4e01-bf75-848337c6fc66
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Medroxyprogesterone Acetate
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA040159
Marketing category: ANDA
Marketing start: 1996-12-04
Marketing end: 0000-00-00
Substance: MEDROXYPROGESTERONE ACETATE
Active strength: 10 mg/1
Pharmacologic classes: Progesterone Congeners [CS],Progestin [EPC]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53002-3570		I	Inactivated by FDA	2026-08-10
excluded package	package	53002-3570	53002-3570-1	I	Inactivated by FDA	2026-08-10
excluded package	package	53002-3570	53002-3570-3	I	Inactivated by FDA	2026-08-10

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 · 33 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-3570-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-3570-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-3570-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-3570-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-3570-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-3570-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-3570-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-3570-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-3570-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-3570-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-3570-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-3570-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-3570-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-3570-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-3570-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-3570-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-3570-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-3570-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-3570-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-3570-3	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-3570-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-3570-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040159-001	MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09
A040159-002	MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	1996-08-09
A040159-003	MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	1996-08-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040159-001	AB
A040159-002	AB
A040159-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A040159-001	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040159-002	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	1996-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040159-003	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	1996-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040159-001	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040159-002	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	1996-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040159-003	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	1996-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040159-001	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040159-002	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	1996-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040159-003	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	1996-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040159-001	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040159-002	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	1996-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040159-003	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	1996-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040159-001	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040159-002	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	1996-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040159-003	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	1996-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040159-001	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040159-002	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	1996-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040159-003	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	1996-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040159-001	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040159-002	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	1996-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040159-003	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	1996-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040159-001	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040159-002	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	1996-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040159-003	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	1996-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040159-001	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040159-002	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	1996-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040159-003	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	1996-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040159-001	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040159-002	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	1996-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040159-003	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	1996-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040159-001	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040159-002	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	1996-08-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040159-003	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	1996-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040159-001	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040159-002	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	1996-08-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040159-003	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	1996-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040159-001	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040159-002	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	1996-08-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040159-003	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	1996-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040159-001	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040159-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040159-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040159-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040159-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040159-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040159-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040159-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040159-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040159-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040159-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040159-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040159-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040159-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040159-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040159-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040159-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040159-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040159-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040159-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040159-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040159-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040159-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040159-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040159-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040159-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040159-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040159-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040159-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040159-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040159-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040159-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040159-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040159-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040159-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040159-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040159-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040159-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040159-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040159-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040159-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dce	Product name	6	20240606
882e78d5-69f7-4a43-812f-1c1628241bbc	Product name	1	20150910
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2	Product name	1	20140508
51a98800-9a04-9e42-2219-e588f17f9e48	Product name	1	20140508
f363ed61-d8ad-8f59-ee92-52a12578e008	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-3570-1	2025-01-30	MedroxyPROGESTERone Acetate Tablets USP
53002-3570-3	2025-01-30	MedroxyPROGESTERone Acetate Tablets USP
53002-3570-1	2023-06-08	MedroxyPROGESTERone Acetate Tablets USP
53002-3570-3	2023-06-08	MedroxyPROGESTERone Acetate Tablets USP
53002-3570-1	2023-01-30	MedroxyPROGESTERone Acetate Tablets USP
53002-3570-3	2023-01-30	MedroxyPROGESTERone Acetate Tablets USP
53002-3570-1	2020-12-16	MedroxyPROGESTERone Acetate Tablets USP
53002-3570-3	2020-12-16	MedroxyPROGESTERone Acetate Tablets USP
53002-3570-1	2020-01-31	MedroxyPROGESTERone Acetate Tablets USP
53002-3570-3	2020-01-31	MedroxyPROGESTERone Acetate Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-3570-1	Medroxyprogesterone Acetate	10 in 1 BOTTLE	TABLET	10		6
53002-3570-3	Medroxyprogesterone Acetate	30 in 1 BOTTLE	TABLET	30		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-3570	MEDROXYPROGESTERONE ACETATE TABLET [RPK PHARMACEUTICALS, INC.]	6	Legacy NDC, 2 package rows	20230609_ceccfb43-ad89-482d-9564-5867df1c936f.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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	REMEDYREPACK INC.	e3dfd683-d44e-427b-af06-70b9b698e016	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Preferred Pharmaceuticals Inc.	a9e05272-aa4e-4df8-b08b-481abca3e8fd	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Preferred Pharmaceuticals, Inc.	37275fd0-eb24-40a4-a93f-b818bb98414e	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	REMEDYREPACK INC.	1020bb60-4f13-4cd7-aaa1-c556752c84b7	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	A-S Medication Solutions	816b9fd2-bc55-496b-846a-cabe7bbdecd6	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Northwind Health Company, LLC	0de6142f-a78e-ae58-e063-6394a90adff0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	American Health Packaging	cbf142f9-9af3-4d79-9343-0ab42d6dbe9f	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	PD-Rx Pharmaceuticals, Inc.	6a541749-5d14-44aa-a409-5e51f5bbf929	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	A-S Medication Solutions	bfdf335d-1cbb-4533-9fde-99a9c71f7504	2025-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	A-S Medication Solutions	788df737-e990-4b5e-accd-af13c3b2bf8b	2025-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Coupler LLC	2cf48919-6de8-d3d0-e063-6394a90ac1bc	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	PD-Rx Pharmaceuticals, Inc.	437edd12-2c08-4df4-8cf7-64c47e4779ac	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Bryant Ranch Prepack	a36c89b7-9463-4d00-a4d3-021d77090077	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Bryant Ranch Prepack	a88b33ff-842b-4a5b-a27e-9c2b9e85a4d7	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Bryant Ranch Prepack	bdb89690-ced2-48e1-bb1a-e5eccfeda8eb	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Bryant Ranch Prepack	d9ad130b-8f9a-4a0f-beb4-b692b6d3c5ca	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	NuCare Pharmaceuticals,Inc.	5c8ffae3-3b3e-197e-e053-2a91aa0a59e3	2024-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Teva Pharmaceuticals USA, Inc.	9eb200b0-db96-4a51-87ea-04db862978c8	2024-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Proficient Rx LP	0df6fd1e-7d9c-4a38-848c-1e562e211c91	2023-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
Medroxyprogesterone	MEDROXYPROGESTERONE	PharmPak, Inc.	1403a9a9-c04a-432f-8819-4850f779312e	2022-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C2QI4IOI2G	MEDROXYPROGESTERONE ACETATE	71-58-9	MEDROXYPROGESTERONE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000114	medroxyPROGESTERone acetate 10 MG Oral Tablet	PSN	ceccfb43-ad89-482d-9564-5867df1c936f	6
1000114	medroxyprogesterone acetate 10 MG Oral Tablet	SCD	ceccfb43-ad89-482d-9564-5867df1c936f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-3570-1	53002357001	10 TABLET in 1 BOTTLE (53002-3570-1)	10 tablet	2018-10-02	0000-00-00	No	No	Current
53002-3570-3	53002357003	30 TABLET in 1 BOTTLE (53002-3570-3)	30 tablet	2018-10-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MedroxyPROGESTERone Acetate Tablets USP	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	6