Medroxyprogesterone Acetate

Product NDC
66336-603
11-digit product format
663360603
Labeler code
66336
Product ID
66336-603_9e7d698d-43c2-4ea4-b5ae-298d3bc2f4d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA040159
Marketing category
ANDA
Marketing start
2011-01-18
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66336-603IInactivated by FDA2026-08-10
excluded packagepackage66336-60366336-603-20IInactivated 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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-603-20IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-603-20IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-603-20IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-603-20IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-603-20IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-603-20IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66336-603-20IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66336-603-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66336-603-20IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66336-603-20IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66336-603-20IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66336-603-20IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66336-603-20IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66336-603-20IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66336-603-20IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66336-603-20IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66336-603-20IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66336-603-20IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66336-603-20IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66336-603-20IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66336-603-20IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66336-603-20EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
66336-603-202020-01-31C16284748780-19d75b9d0-5ba2-f424-e053-dadaa90a57ceMedroxyprogesterone Acetate Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-603-20Medroxyprogesterone Acetate20 in 1 BOTTLETABLET202

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-603MEDROXYPROGESTERONE ACETATE TABLET [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20120929_210a9132-8837-4b8a-829c-abfac2d6e3dc.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
1000141medroxyPROGESTERone acetate 5 MG Oral TabletPSN210a9132-8837-4b8a-829c-abfac2d6e3dc2
1000141medroxyprogesterone acetate 5 MG Oral TabletSCD210a9132-8837-4b8a-829c-abfac2d6e3dc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-603-206633606032020 in 1 BOTTLEHistorical