Progesterone

Product NDC
70934-535
Requested package NDC
70934-535-10
11-digit product format
709340535
Labeler code
70934
Product ID
70934-535_a9e04d56-ca04-586f-e053-2995a90adbd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Progesterone
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA211285
Marketing category
ANDA
Marketing start
2020-02-12
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70934-53570934-535-10IInactivated by FDA2026-08-17

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211285-001PROGESTERONEPROGESTERONE100MGCAPSULE / ORALAB2018-10-26
A211285-002PROGESTERONEPROGESTERONE200MGCAPSULE / ORALAB2018-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211285-001AB
A211285-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211285-001PROGESTERONE100MGCAPSULE / ORALAB2018-10-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211285-002PROGESTERONE200MGCAPSULE / ORALAB2018-10-26bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211285-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211285-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211285-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211285-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211285-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211285-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211285-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211285-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211285-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211285-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211285-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211285-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211285-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211285-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211285-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211285-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211285-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211285-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211285-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211285-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211285-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211285-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211285-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211285-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211285-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211285-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211285-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211285-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211285-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211285-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211285-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211285-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211285-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211285-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211285-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211285-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211285-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211285-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211285-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211285-002AB1bb7c543d1eb4…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-535-102022-01-28C16284748780-1d6a99b3a-011f-a426-e053-dadaa90af4c2Progesterone Capsules 100 mg and 200 mg
70934-535-302022-01-28C16284748780-1d6a99b3a-011f-a426-e053-dadaa90af4c2Progesterone Capsules 100 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-535-10Progesterone10 in 1 BOTTLE, PLASTICCAPSULE101
70934-535-30Progesterone30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-535PROGESTERONE CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]1Legacy NDC, 2 package rows20201224_a9e04d56-ca03-586f-e053-2995a90adbd4.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProgesteronePROGESTERONEREMEDYREPACK INC.f7615864-be6e-47b4-bf35-145a361d7cc62026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211285
application number: ANDA211285
ProgesteronePROGESTERONENorthStar Rx LLCf392c6d9-1420-4735-aa01-f434da9b31b32026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211285
application number: ANDA211285
ProgesteronePROGESTERONEA-S Medication Solutionsbc62ae6d-b609-432d-863f-a8ecd223d69a2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211285
application number: ANDA211285
ProgesteronePROGESTERONEPreferred Pharmaceuticals Inc.eca6a7c0-7f58-4dcf-aec0-9d44fd594aa12026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211285
application number: ANDA211285
ProgesteronePROGESTERONENuCare Pharmaceuticals,Inc.4884017f-3314-cd26-e063-6294a90a4e7e2026-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211285
application number: ANDA211285
ProgesteronePROGESTERONENuCare Pharmaceuticals, Inc.4874ee1b-f661-05f7-e063-6394a90a2b8b2026-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211285
application number: ANDA211285
ProgesteronePROGESTERONENorthwind Health Company, LLCfcebe343-18ac-d4cd-e053-6294a90a72d52026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211285
application number: ANDA211285
ProgesteronePROGESTERONEPreferred Pharmaceuticals Inc.c768aead-153b-42f3-bb4d-b06e30ebad802025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211285
application number: ANDA211285
PROGESTERONEPROGESTERONEdirect rxc33e6c10-3149-57c3-e053-2995a90a3fa12025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211285
application number: ANDA211285
ProgesteronePROGESTERONEBryant Ranch Prepack1c71a4b0-1347-498f-8124-f4cb4be27b612024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211285
application number: ANDA211285
ProgesteronePROGESTERONEBryant Ranch Prepackb74caa23-a5b8-42dd-ab48-4b7a2f015deb2024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211285
application number: ANDA211285
ProgesteronePROGESTERONEAurobindo Pharma Limited7d73f08d-2de7-44b6-9e44-2d488fe025172024-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211285
application number: ANDA211285
ProgesteronePROGESTERONEAsclemed USA, Inc.efd6a8d8-c023-4d9f-b574-b14dc945203d2022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211285
application number: ANDA211285

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260243progesterone 100 MG Oral CapsulePSNa9e04d56-ca03-586f-e053-2995a90adbd41
260243progesterone 100 MG Oral CapsuleSCDa9e04d56-ca03-586f-e053-2995a90adbd41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-535-107093405351010 CAPSULE in 1 BOTTLE, PLASTIC (70934-535-10) 10 capsule2020-02-260000-00-00NoNoCurrent