Progesterone

Product NDC
71335-0835
Requested package NDC
71335-0835-3
11-digit product format
713350835
Labeler code
71335
Product ID
71335-0835_0376baef-6d7b-4fea-a7f3-244c75513611
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Progesterone
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200456
Marketing category
ANDA
Marketing start
2012-10-04
Marketing end
0000-00-00
Substance
PROGESTERONE
Active strength
100 mg/1
Pharmacologic classes
Progesterone [CS], Progesterone [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage71335-083571335-0835-3DDiscontinued by firm2026-08-11
excluded packagepackage71335-083571335-0835-3DDiscontinued by firm2026-08-11

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 · 27 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…
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200456-001PROGESTERONEPROGESTERONE100MGCAPSULE / ORALAB2012-09-28
A200456-002PROGESTERONEPROGESTERONE200MGCAPSULE / ORALAB2012-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A200456-001AB
A200456-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200456-001PROGESTERONE100MGCAPSULE / ORALAB2012-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200456-002PROGESTERONE200MGCAPSULE / ORALAB2012-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200456-001PROGESTERONE100MGCAPSULE / ORALAB2012-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200456-002PROGESTERONE200MGCAPSULE / ORALAB2012-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A200456-001PROGESTERONE100MGCAPSULE / ORALAB2012-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200456-002PROGESTERONE200MGCAPSULE / ORALAB2012-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200456-001PROGESTERONE100MGCAPSULE / ORALAB2012-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200456-002PROGESTERONE200MGCAPSULE / ORALAB2012-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200456-001PROGESTERONE100MGCAPSULE / ORALAB2012-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200456-002PROGESTERONE200MGCAPSULE / ORALAB2012-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200456-001PROGESTERONE100MGCAPSULE / ORALAB2012-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200456-002PROGESTERONE200MGCAPSULE / ORALAB2012-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200456-001PROGESTERONE100MGCAPSULE / ORALAB2012-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200456-002PROGESTERONE200MGCAPSULE / ORALAB2012-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200456-001PROGESTERONE100MGCAPSULE / ORALAB2012-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200456-002PROGESTERONE200MGCAPSULE / ORALAB2012-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200456-001PROGESTERONE100MGCAPSULE / ORALAB2012-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200456-002PROGESTERONE200MGCAPSULE / ORALAB2012-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200456-001PROGESTERONE100MGCAPSULE / ORALAB2012-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A200456-002PROGESTERONE200MGCAPSULE / ORALAB2012-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200456-001PROGESTERONE100MGCAPSULE / ORALAB2012-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200456-002PROGESTERONE200MGCAPSULE / ORALAB2012-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200456-001PROGESTERONE100MGCAPSULE / ORALAB2012-09-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200456-002PROGESTERONE200MGCAPSULE / ORALAB2012-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200456-001PROGESTERONE100MGCAPSULE / ORALAB2012-09-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200456-002PROGESTERONE200MGCAPSULE / ORALAB2012-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200456-001PROGESTERONE100MGCAPSULE / ORALAB2012-09-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200456-002PROGESTERONE200MGCAPSULE / ORALAB2012-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200456-001PROGESTERONE100MGCAPSULE / ORALBX2012-09-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200456-002PROGESTERONE200MGCAPSULE / ORALBX2012-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200456-001PROGESTERONE100MGCAPSULE / ORALBX2012-09-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200456-002PROGESTERONE200MGCAPSULE / ORALBX2012-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200456-001PROGESTERONE100MGCAPSULE / ORALBX2012-09-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200456-002PROGESTERONE200MGCAPSULE / ORALBX2012-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200456-001PROGESTERONE100MGCAPSULE / ORALAB2012-09-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200456-002PROGESTERONE200MGCAPSULE / ORALAB2012-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200456-001PROGESTERONE100MGCAPSULE / ORALBX2012-09-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200456-002PROGESTERONE200MGCAPSULE / ORALBX2012-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200456-001PROGESTERONE100MGCAPSULE / ORALBX2012-09-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A200456-002PROGESTERONE200MGCAPSULE / ORALBX2012-09-28782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200456-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200456-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200456-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200456-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200456-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200456-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200456-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200456-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200456-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200456-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200456-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200456-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200456-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200456-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200456-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200456-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200456-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200456-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200456-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200456-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200456-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200456-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200456-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200456-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200456-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200456-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200456-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200456-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200456-001BX15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200456-002BX15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200456-001BX15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200456-002BX15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200456-001BX14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200456-002BX14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200456-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200456-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200456-001BX1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200456-002BX1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200456-001BX1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200456-002BX1782e0a99824c…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProgesteronePROGESTERONEHikma Pharmaceuticals USA Incd8bcc439-c21d-4eeb-9159-f51e0c60bd702026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200456
application number: ANDA200456

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0835-371335083503100 CAPSULE in 1 BOTTLE (71335-0835-3) 100 capsule2022-02-230000-00-00NoNoCurrent