Medroxyprogesterone Acetate

Product NDC
68071-1870
Requested package NDC
68071-1870-1
11-digit product format
680711870
Labeler code
68071
Product ID
68071-1870_bb26cd3c-8b83-cb42-e053-2995a90a049e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68071-187068071-1870-1DDiscontinued by firm2026-08-10

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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

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…

FDA-Initiated Inactive NDC Indexing#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1870-168071187001100 TABLET in 1 BOTTLE (68071-1870-1) 100 tablet2017-09-220000-00-00NoNoCurrent