MEDROXYPROGESTERONE ACETATE

Product NDC: 50102-591
Requested package NDC: 50102-591-40
11-digit product format: 501020591
Labeler code: 50102
Product ID: 50102-591_392ffaf7-c1c5-414a-8676-78f3cd4e24b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MEDROXYPROGESTERONE ACETATE
Dosage form: INJECTION, SUSPENSION
Route: INTRAMUSCULAR
Labeler: Afaxys Pharma, LLC
Application: ANDA210761
Marketing category: ANDA
Marketing start: 2020-09-21
Marketing end: 0000-00-00
Substance: MEDROXYPROGESTERONE ACETATE
Active strength: 150 mg/mL
Pharmacologic classes: Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50102-591	50102-591-40	D	Discontinued by firm		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 · 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 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
A210761-001	MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION			2019-04-24

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 2 · 42 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
2026-08-18 06:07:40	2026-07	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2019-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2019-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2019-04-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2019-04-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2019-04-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2019-04-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2019-04-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2019-04-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2019-04-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2019-04-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2019-04-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2019-04-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2019-04-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210761-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION		2019-04-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210761-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210761-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210761-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210761-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210761-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210761-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210761-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210761-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210761-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210761-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210761-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210761-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210761-001	AB	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210761-001	AB	1	`cb3db0bc1861…`

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
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	Sun Pharmaceutical Industries, Inc.	01e28bef-9758-40cf-a4ff-86ae9f4f5105	2022-12-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210761 application number: ANDA210761

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50102-591-40	50102059140	1 SYRINGE in 1 CARTON (50102-591-40) > 1 mL in 1 SYRINGE	1 syringe	2020-09-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MEDROXYPROGESTERONE ACETATE	Afaxys Pharma, LLC \| Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2022-12-14	Human Prescription Drug Label	6