Progesterone

Product NDC: 72603-974
Requested package NDC: 72603-974-01
11-digit product format: 726030974
Labeler code: 72603
Product ID: 72603-974_f392c6d9-1420-4735-aa01-f434da9b31b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Progesterone
Dosage form: CAPSULE
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA211285
Marketing category: ANDA
Marketing start: 2026-08-01
Substance: PROGESTERONE
Active strength: 100 mg/1
Pharmacologic classes: Progesterone [CS]; Progesterone [EPC]
Listing certified through: 2027-12-31
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211285-001	PROGESTERONE	PROGESTERONE	100MG	CAPSULE / ORAL	AB		2018-10-26
A211285-002	PROGESTERONE	PROGESTERONE	200MG	CAPSULE / ORAL	AB		2018-10-26

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211285-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2018-10-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211285-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2018-10-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211285-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211285-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211285-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211285-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211285-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211285-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211285-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211285-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211285-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211285-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211285-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211285-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211285-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211285-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211285-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211285-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211285-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211285-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211285-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211285-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211285-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211285-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211285-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211285-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211285-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211285-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211285-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211285-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211285-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211285-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211285-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211285-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211285-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211285-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211285-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211285-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211285-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211285-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211285-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211285-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROGESTERONE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4G7DS2Q64Y	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f392c6d9-1420-4735-aa01-f434da9b31b3	Available on FDA.report

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Progesterone	PROGESTERONE	REMEDYREPACK INC.	f7615864-be6e-47b4-bf35-145a361d7cc6	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211285 application number: ANDA211285
Progesterone	PROGESTERONE	A-S Medication Solutions	bc62ae6d-b609-432d-863f-a8ecd223d69a	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211285 application number: ANDA211285
Progesterone	PROGESTERONE	Preferred Pharmaceuticals Inc.	eca6a7c0-7f58-4dcf-aec0-9d44fd594aa1	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211285 application number: ANDA211285
Progesterone	PROGESTERONE	NuCare Pharmaceuticals,Inc.	4884017f-3314-cd26-e063-6294a90a4e7e	2026-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211285 application number: ANDA211285
Progesterone	PROGESTERONE	NuCare Pharmaceuticals, Inc.	4874ee1b-f661-05f7-e063-6394a90a2b8b	2026-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211285 application number: ANDA211285
Progesterone	PROGESTERONE	Northwind Health Company, LLC	fcebe343-18ac-d4cd-e053-6294a90a72d5	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211285 application number: ANDA211285
Progesterone	PROGESTERONE	Preferred Pharmaceuticals Inc.	c768aead-153b-42f3-bb4d-b06e30ebad80	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211285 application number: ANDA211285
PROGESTERONE	PROGESTERONE	direct rx	c33e6c10-3149-57c3-e053-2995a90a3fa1	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211285 application number: ANDA211285
Progesterone	PROGESTERONE	Bryant Ranch Prepack	1c71a4b0-1347-498f-8124-f4cb4be27b61	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211285 application number: ANDA211285
Progesterone	PROGESTERONE	Bryant Ranch Prepack	b74caa23-a5b8-42dd-ab48-4b7a2f015deb	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211285 application number: ANDA211285
Progesterone	PROGESTERONE	Aurobindo Pharma Limited	7d73f08d-2de7-44b6-9e44-2d488fe02517	2024-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211285 application number: ANDA211285
Progesterone	PROGESTERONE	Asclemed USA, Inc.	efd6a8d8-c023-4d9f-b574-b14dc945203d	2022-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211285 application number: ANDA211285

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4G7DS2Q64Y	PROGESTERONE	57-83-0	PROGESTERONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
72603-974-01	72603097401	100 CAPSULE in 1 BOTTLE (72603-974-01)	100 capsule	2026-08-01	0	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Progesterone Capsules 100 mg and 200 mg Rx only	NorthStar Rx LLC \| EUGIA Pharma Specialities Limited	2026-06-30	Human Prescription Drug Label	1