Progesterone

Product NDC: 68788-4015
11-digit product format: 687884015
Labeler code: 68788
Product ID: 68788-4015_c768aead-153b-42f3-bb4d-b06e30ebad80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Progesterone
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA211285
Marketing category: ANDA
Marketing start: 2025-09-05
Substance: PROGESTERONE
Active strength: 200 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-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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROGESTERONE	200 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
c768aead-153b-42f3-bb4d-b06e30ebad80	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b46148e2-ee15-98d5-12f0-f5ec8745f6fc	Product name	3	20220927
76820076-f087-4073-b1d1-aa04b361335e	Product name	2	20220921
d3229c1a-4e51-4e04-9b13-00d24fd35242	Product name	1	20200821
213f0591-95c1-b398-40b7-08b31f66b026	Product name	4	20190206
85b2d644-53b2-f2dc-4dbc-859116ce56c0	Product name	1	20140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aac	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-4015-3	Progesterone	30 in 1 BOTTLE	CAPSULE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-4015-3	EA - Each	68788-4015	b6484ca0-26e5-42b3-bc6b-2fda46345b11	1	2025-11-13

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 ndc (product): 68788-4015
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312641	progesterone 200 MG Oral Capsule	PSN	c768aead-153b-42f3-bb4d-b06e30ebad80	1
312641	progesterone 200 MG Oral Capsule	SCD	c768aead-153b-42f3-bb4d-b06e30ebad80	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-4015-3	68788401503	30 CAPSULE in 1 BOTTLE (68788-4015-3)	30 capsule	2025-09-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Progesterone Capsules 100 mg and 200 mg Rx only	Preferred Pharmaceuticals Inc.	2025-09-05	HUMAN PRESCRIPTION DRUG LABEL	1