Progesterone

Product NDC
17478-766
11-digit product format
174780766
Labeler code
17478
Product ID
17478-766_c041d019-ffab-4e30-a3d4-3ef61f4d15c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Progesterone
Dosage form
CAPSULE
Route
ORAL
Labeler
Akorn
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 productproduct17478-766DDiscontinued by firm2026-08-11
excluded packagepackage17478-76617478-766-10DDiscontinued 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 · 24 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 packagepackage17478-766-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17478-766-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17478-766-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17478-766-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17478-766-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17478-766-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17478-766-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17478-766-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17478-766-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17478-766-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17478-766-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17478-766-10557ba5c1ecfa…9c80585c8c6e…

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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-766-10EA - Each17478-76670c4f688-d11a-47cb-b18a-b1179f3f5a9f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ProgesteroneACTIVE INGREDIENT4G7DS2Q64YPROGESTERONE CAPSULE [AKORN, INC.]4
ProgesteroneACTIVE MOIETY4G7DS2Q64YPROGESTERONE CAPSULE [AKORN, INC.]4
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GPROGESTERONE CAPSULE [AKORN, INC.]4
FD&C Red NO. 40INACTIVE INGREDIENTWZB9127XOAPROGESTERONE CAPSULE [AKORN, INC.]4
GelatinINACTIVE INGREDIENT2G86QN327LPROGESTERONE CAPSULE [AKORN, INC.]4
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPROGESTERONE CAPSULE [AKORN, INC.]4
Lecithin, SoybeanINACTIVE INGREDIENT1DI56QDM62PROGESTERONE CAPSULE [AKORN, INC.]4
Peanut OilINACTIVE INGREDIENT5TL50QU0W4PROGESTERONE CAPSULE [AKORN, INC.]4
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPPROGESTERONE CAPSULE [AKORN, INC.]4

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260243progesterone 100 MG Oral CapsulePSN66945b9f-b387-4e99-bd38-121626418a9910
260243progesterone 100 MG Oral CapsuleSCD66945b9f-b387-4e99-bd38-121626418a9910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-766-1017478076610100 CAPSULE in 1 BOTTLE, PLASTIC (17478-766-10) 100 capsule2012-10-040000-00-00NoNoCurrent