medroxyprogesterone acetate

Product NDC: 43063-438
11-digit product format: 430630438
Labeler code: 43063
Product ID: 43063-438_c8c22709-cf45-9ef4-e053-2a95a90afaf9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: medroxyprogesterone acetate
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: NDA011839
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1959-06-03
Marketing end: 2022-12-31
Substance: MEDROXYPROGESTERONE ACETATE
Active strength: 10 mg/1
Pharmacologic classes: Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43063-438		D	Discontinued by firm	2026-08-17
excluded package	package	43063-438	43063-438-05	D	Discontinued by firm	2026-08-17
excluded package	package	43063-438	43063-438-07	D	Discontinued by firm	2026-08-17
excluded package	package	43063-438	43063-438-10	D	Discontinued by firm	2026-08-17
excluded package	package	43063-438	43063-438-13	D	Discontinued by firm	2026-08-17
excluded package	package	43063-438	43063-438-30	D	Discontinued by firm	2026-08-17
excluded package	package	43063-438	43063-438-40	D	Discontinued by firm	2026-08-17
excluded package	package	43063-438	43063-438-42	D	Discontinued by firm	2026-08-17
excluded package	package	43063-438	43063-438-50	D	Discontinued by firm	2026-08-17
excluded package	package	43063-438	43063-438-90	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 2 · 120 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	43063-438-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-438-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-438-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-438-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-438-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-438-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-438-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-438-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-438-42	`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	43063-438-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-438-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-438-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-438-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-438-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-438-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-438-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-438-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-438-42	`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	43063-438-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-438-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-438-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-438-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-438-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-438-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-438-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-438-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-438-42	`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	43063-438-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-438-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-438-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-438-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-438-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-438-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-438-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-438-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-438-42	`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	43063-438-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-438-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-438-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-438-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-438-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-438-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-438-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-438-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-438-42	`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	43063-438-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-438-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-438-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-438-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-438-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-438-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-438-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-438-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-438-42	`cdf11ea48f46…`	`ba0047e9e063…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS
N011839-001	PROVERA	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982
N011839-003	PROVERA	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	RLD, Approved before 1982
N011839-004	PROVERA	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N011839-001	AB
N011839-003	AB
N011839-004	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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N011839-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011839-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011839-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N011839-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011839-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011839-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011839-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011839-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011839-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011839-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011839-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011839-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011839-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011839-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011839-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011839-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011839-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011839-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011839-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011839-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011839-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011839-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011839-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011839-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011839-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011839-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011839-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011839-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011839-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011839-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011839-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011839-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011839-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011839-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011839-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011839-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011839-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011839-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011839-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011839-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-438-05	EA - Each	43063-438	a98fc404-3431-4991-bded-3627883f087b	1	2013-04-01
43063-438-10	EA - Each	43063-438	3cfe2ff8-a42e-49a9-98d4-ad033bf5637c	1	2013-05-02
43063-438-90	EA - Each	43063-438	0e95b047-9253-41c4-97d9-1fadfc196f54	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MEDROXYPROGESTERONE ACETATE	ACTIVE INGREDIENT	C2QI4IOI2G	MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE ACETATE) TABLET [PD-RX PHARMACEUTICALS, INC.]	8
MEDROXYPROGESTERONE	ACTIVE MOIETY	HSU1C9YRES	MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE ACETATE) TABLET [PD-RX PHARMACEUTICALS, INC.]	8
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE ACETATE) TABLET [PD-RX PHARMACEUTICALS, INC.]	8
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE ACETATE) TABLET [PD-RX PHARMACEUTICALS, INC.]	8
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE ACETATE) TABLET [PD-RX PHARMACEUTICALS, INC.]	8
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE ACETATE) TABLET [PD-RX PHARMACEUTICALS, INC.]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE ACETATE) TABLET [PD-RX PHARMACEUTICALS, INC.]	8
SUCROSE	INACTIVE INGREDIENT	C151H8M554	MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE ACETATE) TABLET [PD-RX PHARMACEUTICALS, INC.]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE ACETATE) TABLET [PD-RX PHARMACEUTICALS, INC.]	8

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Provera	MEDROXYPROGESTERONE ACETATE	Pharmacia & Upjohn Company LLC	a586be28-96af-4fed-a13f-9b94fd4c7405	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 011839 application number: NDA011839
medroxyprogesterone acetate	MEDROXYPROGESTERONE ACETATE	Mylan Pharmaceuticals Inc.	2627eb11-06bf-4a45-9172-094468e3ca07	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 011839 application number: NDA011839

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
43063-438-05	43063043805	5 TABLET in 1 BOTTLE, PLASTIC (43063-438-05)	5 tablet	2013-03-01	0000-00-00	No	No	Current
43063-438-07	43063043807	7 TABLET in 1 BOTTLE, PLASTIC (43063-438-07)	7 tablet	2013-03-01	0000-00-00	No	No	Current
43063-438-10	43063043810	10 TABLET in 1 BOTTLE, PLASTIC (43063-438-10)	10 tablet	2013-03-01	0000-00-00	No	No	Current
43063-438-13	43063043813	13 TABLET in 1 BOTTLE, PLASTIC (43063-438-13)	13 tablet	2013-03-01	0000-00-00	No	No	Current
43063-438-30	43063043830	30 TABLET in 1 BOTTLE, PLASTIC (43063-438-30)	30 tablet	2013-03-01	0000-00-00	No	No	Current
43063-438-40	43063043840	40 TABLET in 1 BOTTLE, PLASTIC (43063-438-40)	40 tablet	2013-03-01	0000-00-00	No	No	Current
43063-438-42	43063043842	42 TABLET in 1 BOTTLE, PLASTIC (43063-438-42)	42 tablet	2013-03-01	0000-00-00	No	No	Current
43063-438-50	43063043850	50 TABLET in 1 BOTTLE, PLASTIC (43063-438-50)	50 tablet	2013-03-01	0000-00-00	No	No	Current
43063-438-90	43063043890	90 TABLET in 1 BOTTLE, PLASTIC (43063-438-90)	90 tablet	2013-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Medroxyprogesterone Acetate Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2021-08-04	HUMAN PRESCRIPTION DRUG LABEL	17