Progesterone

Product NDC
69543-374
11-digit product format
695430374
Labeler code
69543
Product ID
69543-374_2ed02d5f-7930-444e-842f-207821d6b3e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Progesterone
Dosage form
CAPSULE
Route
ORAL
Labeler
Virtus Pharmaceuticals
Application
NDA019781
Marketing category
NDA
Marketing start
2016-07-13
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
2021-12-31
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 productproduct69543-374DDiscontinued by firm2026-08-11
excluded packagepackage69543-37469543-374-10DDiscontinued 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 · 4 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 packagepackage69543-374-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69543-374-10f5e01cc5f278…a2eaf40c39c3…

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
N019781-001PROMETRIUMPROGESTERONE100MGCAPSULE / ORALABRLD1998-05-14
N019781-002PROMETRIUMPROGESTERONE200MGCAPSULE / ORALABRLD, RS1999-10-15
N019781-003PROMETRIUMPROGESTERONE300MGCAPSULE / ORAL1999-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019781-001AB
N019781-002AB

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 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 UTC2026-02N019781-001PROMETRIUM100MGCAPSULE / ORALABRLD1998-05-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019781-002PROMETRIUM200MGCAPSULE / ORALABRLD, RS1999-10-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019781-003PROMETRIUM300MGCAPSULE / ORAL1999-10-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019781-001PROMETRIUM100MGCAPSULE / ORALABRLD1998-05-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019781-002PROMETRIUM200MGCAPSULE / ORALABRLD, RS1999-10-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019781-003PROMETRIUM300MGCAPSULE / ORAL1999-10-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N019781-001PROMETRIUM100MGCAPSULE / ORALABRLD1998-05-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019781-002PROMETRIUM200MGCAPSULE / ORALABRLD, RS1999-10-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019781-003PROMETRIUM300MGCAPSULE / ORAL1999-10-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019781-001PROMETRIUM100MGCAPSULE / ORALABRLD1998-05-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019781-002PROMETRIUM200MGCAPSULE / ORALABRLD, RS1999-10-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019781-003PROMETRIUM300MGCAPSULE / ORAL1999-10-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019781-001PROMETRIUM100MGCAPSULE / ORALABRLD1998-05-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019781-002PROMETRIUM200MGCAPSULE / ORALABRLD, RS1999-10-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019781-003PROMETRIUM300MGCAPSULE / ORAL1999-10-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019781-001PROMETRIUM100MGCAPSULE / ORALABRLD1998-05-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019781-002PROMETRIUM200MGCAPSULE / ORALABRLD, RS1999-10-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019781-003PROMETRIUM300MGCAPSULE / ORAL1999-10-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019781-001PROMETRIUM100MGCAPSULE / ORALABRLD1998-05-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019781-002PROMETRIUM200MGCAPSULE / ORALABRLD, RS1999-10-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019781-003PROMETRIUM300MGCAPSULE / ORAL1999-10-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019781-001PROMETRIUM100MGCAPSULE / ORALABRLD1998-05-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019781-002PROMETRIUM200MGCAPSULE / ORALABRLD, RS1999-10-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019781-003PROMETRIUM300MGCAPSULE / ORAL1999-10-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019781-001PROMETRIUM100MGCAPSULE / ORALABRLD1998-05-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019781-002PROMETRIUM200MGCAPSULE / ORALABRLD, RS1999-10-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019781-003PROMETRIUM300MGCAPSULE / ORAL1999-10-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019781-001PROMETRIUM100MGCAPSULE / ORALABRLD1998-05-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N019781-002PROMETRIUM200MGCAPSULE / ORALABRLD, RS1999-10-15d06236e962d9…
2024-10-29 15:01 UTC2024-10N019781-003PROMETRIUM300MGCAPSULE / ORAL1999-10-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019781-001PROMETRIUM100MGCAPSULE / ORALABRLD1998-05-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019781-002PROMETRIUM200MGCAPSULE / ORALABRLD, RS1999-10-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019781-003PROMETRIUM300MGCAPSULE / ORAL1999-10-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019781-001PROMETRIUM100MGCAPSULE / ORALABRLD1998-05-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019781-002PROMETRIUM200MGCAPSULE / ORALABRLD, RS1999-10-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019781-003PROMETRIUM300MGCAPSULE / ORAL1999-10-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019781-001PROMETRIUM100MGCAPSULE / ORALABRLD1998-05-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019781-002PROMETRIUM200MGCAPSULE / ORALABRLD, RS1999-10-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019781-003PROMETRIUM300MGCAPSULE / ORAL1999-10-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019781-001PROMETRIUM100MGCAPSULE / ORALABRLD1998-05-148072bd15b7f6…

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 UTC2026-02N019781-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019781-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019781-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019781-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019781-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019781-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019781-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019781-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019781-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019781-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019781-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019781-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019781-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019781-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019781-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019781-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019781-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019781-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019781-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019781-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019781-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019781-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019781-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019781-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019781-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019781-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019781-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019781-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019781-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019781-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019781-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019781-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019781-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019781-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019781-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019781-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019781-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019781-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019781-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N019781-002AB1782e0a99824c…

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69543-374PROGESTERONE CAPSULE [VIRTUS PHARMACEUTICALS]6Legacy NDC20241120_2fac2189-5d9d-4408-a1cf-b6bbdf643adc.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrometriumPROGESTERONEAcertis Pharmaceuticals, LLC1cf237ff-c4f8-4faa-a7aa-77599c8568892026-07-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 019781
application number: NDA019781

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260243progesterone 100 MG Oral CapsulePSN49f70b80-74b4-40f5-af86-5651441176a65
260243progesterone 100 MG Oral CapsuleSCD49f70b80-74b4-40f5-af86-5651441176a65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69543-374-1069543037410100 CAPSULE in 1 BOTTLE (69543-374-10) 100 capsule2016-07-130000-00-00NoNoCurrent