Application 040159

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	TABLET;ORAL	2.5MG	No	No
002	MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	TABLET;ORAL	5MG	No	No
003	MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	TABLET;ORAL	10MG	No	No

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

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 · 129 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	A040159-001	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040159-002	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	1996-08-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040159-003	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	1996-08-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040159-001	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	1996-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040159-002	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	1996-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040159-003	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	1996-08-09	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A040159-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040159-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040159-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040159-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040159-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040159-003	AB	1	`caaa826d4ba7…`
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…`

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.	1020bb60-4f13-4cd7-aaa1-c556752c84b7	2026-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040159 application number: ANDA040159
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	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 ndc (product): 72789-043
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 82 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72789-043	Medroxyprogesterone Acetate	Medroxyprogesterone Acetate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-043	Medroxyprogesterone Acetate	Medroxyprogesterone Acetate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current