Medroxyprogesterone Acetate
- Product NDC
- 10544-001
- 11-digit product format
- 105440001
- Labeler code
- 10544
- Product ID
- 10544-001_11b99f8b-d06a-50c3-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Medroxyprogesterone Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA040159
- Marketing category
- ANDA
- Marketing start
- 2010-05-20
- Marketing end
- 0000-00-00
- Substance
- MEDROXYPROGESTERONE ACETATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Progesterone Congeners [CS],Progestin [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 10544-001 | I | Inactivated by FDA | 2026-08-10 | ||
| excluded package | package | 10544-001 | 10544-001-30 | 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.
| 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 | 10544-001-30 | 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 | 10544-001-30 | 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 | 10544-001-30 | 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 | 10544-001-30 | 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 | 10544-001-30 | 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 | 10544-001-30 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 10544-001-30 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 10544-001-30 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 10544-001-30 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 10544-001-30 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 10544-001-30 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 10544-001-30 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 10544-001-30 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 10544-001-30 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 10544-001-30 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 10544-001-30 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 10544-001-30 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 10544-001-30 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 10544-001-30 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 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 | 10544-001-30 | 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 | 10544-001-30 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 10544-001-30 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | 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#
| 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 | 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 | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10544-001-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5a73-f424-e053-dadaa90a57ce | Medroxyprogesterone Acetate Tablets USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10544-001-30 | Medroxyprogesterone Acetate | 30 in 1 BOTTLE | TABLET | 30 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10544-001-30 | EA - Each | 10544-001 | 69d078a6-cd2f-4c2b-a746-ee389a983cdd | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MEDROXYPROGESTERONE ACETATE | ACTIVE INGREDIENT | C2QI4IOI2G | MEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| MEDROXYPROGESTERONE | ACTIVE MOIETY | HSU1C9YRES | MEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | MEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| METHYLCELLULOSE (15 MPA.S) | INACTIVE INGREDIENT | NPU9M2E6L8 | MEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | MEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.] | 3 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | REMEDYREPACK INC. | e3dfd683-d44e-427b-af06-70b9b698e016 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Preferred Pharmaceuticals Inc. | a9e05272-aa4e-4df8-b08b-481abca3e8fd | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Preferred Pharmaceuticals, Inc. | 37275fd0-eb24-40a4-a93f-b818bb98414e | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | REMEDYREPACK INC. | 1020bb60-4f13-4cd7-aaa1-c556752c84b7 | 2026-05-27 | Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | A-S Medication Solutions | 816b9fd2-bc55-496b-846a-cabe7bbdecd6 | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Northwind Health Company, LLC | 0de6142f-a78e-ae58-e063-6394a90adff0 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | American Health Packaging | cbf142f9-9af3-4d79-9343-0ab42d6dbe9f | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | PD-Rx Pharmaceuticals, Inc. | 6a541749-5d14-44aa-a409-5e51f5bbf929 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | A-S Medication Solutions | bfdf335d-1cbb-4533-9fde-99a9c71f7504 | 2025-06-12 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | A-S Medication Solutions | 788df737-e990-4b5e-accd-af13c3b2bf8b | 2025-06-12 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Coupler LLC | 2cf48919-6de8-d3d0-e063-6394a90ac1bc | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | PD-Rx Pharmaceuticals, Inc. | 437edd12-2c08-4df4-8cf7-64c47e4779ac | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Bryant Ranch Prepack | a36c89b7-9463-4d00-a4d3-021d77090077 | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Bryant Ranch Prepack | a88b33ff-842b-4a5b-a27e-9c2b9e85a4d7 | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Bryant Ranch Prepack | bdb89690-ced2-48e1-bb1a-e5eccfeda8eb | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Bryant Ranch Prepack | d9ad130b-8f9a-4a0f-beb4-b692b6d3c5ca | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | NuCare Pharmaceuticals,Inc. | 5c8ffae3-3b3e-197e-e053-2a91aa0a59e3 | 2024-06-04 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Teva Pharmaceuticals USA, Inc. | 9eb200b0-db96-4a51-87ea-04db862978c8 | 2024-03-01 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Proficient Rx LP | 0df6fd1e-7d9c-4a38-848c-1e562e211c91 | 2023-02-01 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
| Medroxyprogesterone | MEDROXYPROGESTERONE | PharmPak, Inc. | 1403a9a9-c04a-432f-8819-4850f779312e | 2022-10-09 | Boxed warning, Warnings, Adverse reactions | 040159 ANDA040159 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1000114 | medroxyPROGESTERone acetate 10 MG Oral Tablet | PSN | 826f674c-8ef2-400a-bf0b-877320a8cb5d | 3 |
| 1000141 | medroxyPROGESTERone acetate 5 MG Oral Tablet | PSN | 826f674c-8ef2-400a-bf0b-877320a8cb5d | 3 |
| 1000114 | medroxyprogesterone acetate 10 MG Oral Tablet | SCD | 826f674c-8ef2-400a-bf0b-877320a8cb5d | 3 |
| 1000141 | medroxyprogesterone acetate 5 MG Oral Tablet | SCD | 826f674c-8ef2-400a-bf0b-877320a8cb5d | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 10544-001-30 | 10544000130 | 30 in 1 BOTTLE | Historical |