Medroxyprogesterone Acetate

Product NDC
33261-609
11-digit product format
332610609
Labeler code
33261
Product ID
33261-609_625f2552-b7bf-4ee3-a58e-9e22578f2280
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA040159
Marketing category
ANDA
Marketing start
1996-12-04
Marketing end
0000-00-00
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
3 mg/1
Pharmacologic classes
Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-609IInactivated by FDA2026-08-10
excluded packagepackage33261-60933261-609-30IInactivated by FDA2026-08-10

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.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-609-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-609-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-609-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-609-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-609-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-609-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-609-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-609-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-609-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-609-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-609-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-609-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-609-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-609-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-609-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage33261-609-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage33261-609-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage33261-609-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage33261-609-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage33261-609-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage33261-609-309bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040159-001MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-09
A040159-002MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-09
A040159-003MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040159-001AB
A040159-002AB
A040159-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-098072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040159-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040159-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040159-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040159-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040159-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040159-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040159-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040159-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040159-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040159-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040159-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040159-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040159-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040159-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040159-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040159-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040159-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040159-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040159-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040159-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040159-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040159-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040159-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040159-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040159-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040159-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040159-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040159-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040159-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040159-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040159-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040159-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040159-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040159-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040159-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040159-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040159-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040159-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040159-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040159-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dceProduct name620240606
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2Product name120140508
51a98800-9a04-9e42-2219-e588f17f9e48Product name120140508
f363ed61-d8ad-8f59-ee92-52a12578e008Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-609-302020-01-31C16284748780-19d75b9cf-f1c1-f424-e053-dadaa90a57ceMedroxyprogesterone Acetate Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-609-30Medroxyprogesterone Acetate30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-609-30EA - Each33261-609c09f61cf-b06c-4121-b49a-1d720ea9811e12015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-609MEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140128_fda3368b-4ce3-4972-885d-066858831ee0.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEREMEDYREPACK INC.e3dfd683-d44e-427b-af06-70b9b698e0162026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPreferred Pharmaceuticals Inc.a9e05272-aa4e-4df8-b08b-481abca3e8fd2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPreferred Pharmaceuticals, Inc.37275fd0-eb24-40a4-a93f-b818bb98414e2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEREMEDYREPACK INC.1020bb60-4f13-4cd7-aaa1-c556752c84b72026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutions816b9fd2-bc55-496b-846a-cabe7bbdecd62026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATENorthwind Health Company, LLC0de6142f-a78e-ae58-e063-6394a90adff02026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEAmerican Health Packagingcbf142f9-9af3-4d79-9343-0ab42d6dbe9f2025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPD-Rx Pharmaceuticals, Inc.6a541749-5d14-44aa-a409-5e51f5bbf9292025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutionsbfdf335d-1cbb-4533-9fde-99a9c71f75042025-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutions788df737-e990-4b5e-accd-af13c3b2bf8b2025-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATECoupler LLC2cf48919-6de8-d3d0-e063-6394a90ac1bc2025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPD-Rx Pharmaceuticals, Inc.437edd12-2c08-4df4-8cf7-64c47e4779ac2025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEBryant Ranch Prepacka36c89b7-9463-4d00-a4d3-021d770900772024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEBryant Ranch Prepacka88b33ff-842b-4a5b-a27e-9c2b9e85a4d72024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEBryant Ranch Prepackbdb89690-ced2-48e1-bb1a-e5eccfeda8eb2024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEBryant Ranch Prepackd9ad130b-8f9a-4a0f-beb4-b692b6d3c5ca2024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATENuCare Pharmaceuticals,Inc.5c8ffae3-3b3e-197e-e053-2a91aa0a59e32024-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATETeva Pharmaceuticals USA, Inc.9eb200b0-db96-4a51-87ea-04db862978c82024-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEProficient Rx LP0df6fd1e-7d9c-4a38-848c-1e562e211c912023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
MedroxyprogesteroneMEDROXYPROGESTERONEPharmPak, Inc.1403a9a9-c04a-432f-8819-4850f779312e2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSNfda3368b-4ce3-4972-885d-066858831ee01
1000135medroxyPROGESTERone acetate 2.5 MG Oral TabletPSNfda3368b-4ce3-4972-885d-066858831ee01
1000141medroxyPROGESTERone acetate 5 MG Oral TabletPSNfda3368b-4ce3-4972-885d-066858831ee01
1000114medroxyprogesterone acetate 10 MG Oral TabletSCDfda3368b-4ce3-4972-885d-066858831ee01
1000135medroxyprogesterone acetate 2.5 MG Oral TabletSCDfda3368b-4ce3-4972-885d-066858831ee01
1000141medroxyprogesterone acetate 5 MG Oral TabletSCDfda3368b-4ce3-4972-885d-066858831ee01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-609-303326106093030 in 1 BOTTLE, PLASTICHistorical