medroxyprogesterone acetate
- Product NDC
- 59762-3740
- Requested package NDC
- 59762-3740-5
- 11-digit product format
- 597623740
- Labeler code
- 59762
- Product ID
- 59762-3740_79175bd0-479f-4b42-b7f3-35a7fb840192
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- medroxyprogesterone acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Greenstone LLC
- Application
- NDA011839
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 1959-06-03
- Marketing end
- 2023-01-31
- Substance
- MEDROXYPROGESTERONE ACETATE
- Active strength
- 3 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 59762-3740 | 59762-3740-5 | 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.
| 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… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | 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#
| 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 Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dce | Product name | 6 | 20240606 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59762-3740-1 | EA - Each | 59762-3740 | 299323d8-e9c6-42fe-a833-5dd18c8ac8de | 1 | 2012-07-24 |
| 59762-3740-5 | EA - Each | 59762-3740 | 282c5ee9-6dbe-4ff8-b54d-5a4858c4faed | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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.
| 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 | 011839 NDA011839 |
| medroxyprogesterone acetate | MEDROXYPROGESTERONE ACETATE | Mylan Pharmaceuticals Inc. | 2627eb11-06bf-4a45-9172-094468e3ca07 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 011839 NDA011839 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1000114 | medroxyPROGESTERone acetate 10 MG Oral Tablet | PSN | 499051ac-ffaf-4db4-be45-a409bd54991f | 1 |
| 1000135 | medroxyPROGESTERone acetate 2.5 MG Oral Tablet | PSN | 1b67cd36-7199-42ff-a8a7-cecc81679676 | 1 |
| 1000135 | medroxyPROGESTERone acetate 2.5 MG Oral Tablet | PSN | 499051ac-ffaf-4db4-be45-a409bd54991f | 1 |
| 1000141 | medroxyPROGESTERone acetate 5 MG Oral Tablet | PSN | 499051ac-ffaf-4db4-be45-a409bd54991f | 1 |
| 1000114 | medroxyprogesterone acetate 10 MG Oral Tablet | SCD | 499051ac-ffaf-4db4-be45-a409bd54991f | 1 |
| 1000135 | medroxyprogesterone acetate 2.5 MG Oral Tablet | SCD | 1b67cd36-7199-42ff-a8a7-cecc81679676 | 1 |
| 1000135 | medroxyprogesterone acetate 2.5 MG Oral Tablet | SCD | 499051ac-ffaf-4db4-be45-a409bd54991f | 1 |
| 1000141 | medroxyprogesterone acetate 5 MG Oral Tablet | SCD | 499051ac-ffaf-4db4-be45-a409bd54991f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59762-3740-5 | 59762374005 | 1 BOTTLE in 1 CARTON (59762-3740-5) > 1000 TABLET in 1 BOTTLE | 1 bottle | 1959-06-03 | 2022-05-31 | No | No | Current |