PROGESTERONE

Product NDC
69452-233
11-digit product format
694520233
Labeler code
69452
Product ID
69452-233_3e777dbd-754b-9d2e-e063-6294a90a42a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROGESTERONE
Dosage form
CAPSULE
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA200900
Marketing category
ANDA
Marketing start
2018-11-28
Substance
PROGESTERONE
Active strength
100 mg/1
Pharmacologic classes
Progesterone [CS], Progesterone [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A200900-001PROGESTERONEPROGESTERONE100MGCAPSULE / ORALAB2013-08-16
A200900-002PROGESTERONEPROGESTERONE200MGCAPSULE / ORALAB2013-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200900-001AB
A200900-002AB

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 UTC2026-02A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200900-001PROGESTERONE100MGCAPSULE / ORALAB2013-08-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A200900-002PROGESTERONE200MGCAPSULE / ORALAB2013-08-16782e0a99824c…

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 UTC2026-02A200900-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200900-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200900-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200900-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200900-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200900-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200900-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200900-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200900-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200900-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200900-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200900-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200900-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200900-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200900-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200900-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200900-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200900-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200900-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200900-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200900-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200900-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200900-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200900-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200900-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200900-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200900-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200900-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200900-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200900-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200900-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200900-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200900-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200900-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200900-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200900-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200900-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200900-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200900-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200900-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
PROGESTERONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROGESTERONE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4G7DS2Q64YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
260243Internal RxNorm lookup
312641Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
41b3c3a7-5fb8-4451-a96c-2bd02613c021Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-233-20PROGESTERONE100 in 1 BOTTLECAPSULE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-233-20EA - Each69452-233993b5a26-3309-4ae6-854c-fa0b75db60bf12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-233PROGESTERONE CAPSULE [BIONPHARMA INC.]3Current NDC, Legacy NDC, 1 package rows20250308_41b3c3a7-5fb8-4451-a96c-2bd02613c021.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
PROGESTERONEPROGESTERONEGolden State Medical Supply, Inc.312db3af-9dd2-d5e4-e063-6394a90af9992026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200900
application number: ANDA200900
PROGESTERONEPROGESTERONEBionpharma Inc.41b3c3a7-5fb8-4451-a96c-2bd02613c0212026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200900
application number: ANDA200900
ndc (product): 69452-233
PROGESTERONEPROGESTERONEA-S Medication Solutions566584fc-c76a-4e42-a62e-109a2903b9392026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200900
application number: ANDA200900
PROGESTERONEPROGESTERONEProficient Rx LP199c8575-e113-468f-8eb7-c4930030649c2026-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200900
application number: ANDA200900
PROGESTERONEPROGESTERONEBryant Ranch Prepack46d97ca6-970f-478f-81ff-1b9a9f6cb2f72026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200900
application number: ANDA200900
PROGESTERONEPROGESTERONENuCare Pharmaceuticals,Inc.0b3da881-4720-cdee-e063-6394a90aee992025-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200900
application number: ANDA200900
PROGESTERONEPROGESTERONEREMEDYREPACK INC.947ebb7c-492b-4b83-aa1c-81e282df64212025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200900
application number: ANDA200900
PROGESTERONEPROGESTERONEPreferred Pharmaceuticals Inc.41c9546c-a854-4395-9506-d1be61f4e60f2025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200900
application number: ANDA200900
PROGESTERONEPROGESTERONEPreferred Pharmaceuticals Inc.404e0b45-339b-4304-8e33-5f4ffe8f8e252025-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200900
application number: ANDA200900
PROGESTERONEPROGESTERONEBryant Ranch Prepack0aeb0f0f-2749-416b-942f-83950200fd752025-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200900
application number: ANDA200900
PROGESTERONEPROGESTERONEAsclemed USA, Inc.342a096d-df6f-47de-bdd1-ec259638e4762025-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200900
application number: ANDA200900
PROGESTERONEPROGESTERONENuCare Pharmaceuticals,Inc.0d976866-81b3-5db8-e063-6294a90a39f92024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200900
application number: ANDA200900
PROGESTERONEPROGESTERONEBionpharma Inc.3acad9b0-7ec6-4d5e-9852-32ffadbbed6d2018-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200900
application number: ANDA200900

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260243progesterone 100 MG Oral CapsulePSN0aeb0f0f-2749-416b-942f-83950200fd75102
260243progesterone 100 MG Oral CapsuleSCD0aeb0f0f-2749-416b-942f-83950200fd75102
260243progesterone 100 MG Oral CapsulePSN41b3c3a7-5fb8-4451-a96c-2bd02613c0215
312641progesterone 200 MG Oral CapsulePSN41b3c3a7-5fb8-4451-a96c-2bd02613c0215
260243progesterone 100 MG Oral CapsuleSCD41b3c3a7-5fb8-4451-a96c-2bd02613c0215
312641progesterone 200 MG Oral CapsuleSCD41b3c3a7-5fb8-4451-a96c-2bd02613c0215
260243progesterone 100 MG Oral CapsulePSN0d976866-81b3-5db8-e063-6294a90a39f94
260243progesterone 100 MG Oral CapsuleSCD0d976866-81b3-5db8-e063-6294a90a39f94
260243progesterone 100 MG Oral CapsulePSN947ebb7c-492b-4b83-aa1c-81e282df64213
260243progesterone 100 MG Oral CapsulePSN566584fc-c76a-4e42-a62e-109a2903b9393
260243progesterone 100 MG Oral CapsuleSCD947ebb7c-492b-4b83-aa1c-81e282df64213
260243progesterone 100 MG Oral CapsuleSCD566584fc-c76a-4e42-a62e-109a2903b9393
260243progesterone 100 MG Oral CapsulePSN404e0b45-339b-4304-8e33-5f4ffe8f8e252
260243progesterone 100 MG Oral CapsulePSN342a096d-df6f-47de-bdd1-ec259638e4762
260243progesterone 100 MG Oral CapsulePSN312db3af-9dd2-d5e4-e063-6394a90af9992
312641progesterone 200 MG Oral CapsulePSN342a096d-df6f-47de-bdd1-ec259638e4762
312641progesterone 200 MG Oral CapsulePSN312db3af-9dd2-d5e4-e063-6394a90af9992
260243progesterone 100 MG Oral CapsuleSCD404e0b45-339b-4304-8e33-5f4ffe8f8e252
260243progesterone 100 MG Oral CapsuleSCD342a096d-df6f-47de-bdd1-ec259638e4762
260243progesterone 100 MG Oral CapsuleSCD312db3af-9dd2-d5e4-e063-6394a90af9992
312641progesterone 200 MG Oral CapsuleSCD342a096d-df6f-47de-bdd1-ec259638e4762
312641progesterone 200 MG Oral CapsuleSCD312db3af-9dd2-d5e4-e063-6394a90af9992

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-233-2069452023320100 CAPSULE in 1 BOTTLE (69452-233-20) 100 capsule2018-11-280000-00-00NoNoCurrent