Progesterone

Product NDC: 65162-807
11-digit product format: 651620807
Labeler code: 65162
Product ID: 65162-807_6f7c3e58-3b68-4d6f-8502-74a41478d1c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Progesterone
Dosage form: CAPSULE
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA207724
Marketing category: ANDA
Marketing start: 2017-09-11
Substance: PROGESTERONE
Active strength: 100 mg/1
Pharmacologic classes: Progesterone [CS], Progesterone [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207724-001	PROGESTERONE	PROGESTERONE	100MG	CAPSULE / ORAL	AB		2017-09-07
A207724-002	PROGESTERONE	PROGESTERONE	200MG	CAPSULE / ORAL	AB		2017-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207724-001	AB
A207724-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207724-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207724-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207724-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207724-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207724-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207724-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207724-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207724-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207724-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207724-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207724-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207724-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207724-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207724-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207724-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207724-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207724-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207724-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207724-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207724-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207724-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207724-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207724-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207724-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207724-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207724-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207724-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207724-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207724-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207724-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207724-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207724-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207724-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207724-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207724-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207724-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207724-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207724-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207724-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207724-002	AB	1	`bb7c543d1eb4…`

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
260243	Internal RxNorm lookup
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
4de0715d-a3b9-42fa-b4e4-6371151fd75c	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
65162-807-10	Progesterone	100 in 1 BOTTLE	CAPSULE	100		13
65162-807-50	Progesterone	500 in 1 BOTTLE	CAPSULE	500		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-807-10	EA - Each	65162-807	b25d4f37-3cf4-4812-b174-7a3ff9f79db1	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-807	PROGESTERONE CAPSULE [AMNEAL PHARMACEUTICALS LLC]	12	Current NDC, Legacy NDC, 2 package rows	20240425_4de0715d-a3b9-42fa-b4e4-6371151fd75c.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Progesterone	PROGESTERONE	AvKARE	42c84fec-e5eb-78f7-e063-6294a90a4c0e	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207724 application number: ANDA207724
Progesterone	PROGESTERONE	Amneal Pharmaceuticals LLC	4de0715d-a3b9-42fa-b4e4-6371151fd75c	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207724 application number: ANDA207724 ndc (product): 65162-807
Progesterone	PROGESTERONE	REMEDYREPACK INC.	d7619751-47b4-47c9-b716-e2a704b350c8	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207724 application number: ANDA207724
Progesterone	PROGESTERONE	Bryant Ranch Prepack	1220b231-4765-4879-acb8-d7887d863a28	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207724 application number: ANDA207724
Progesterone	PROGESTERONE	Asclemed USA, Inc.	19716042-8025-43a3-b26d-e0fd7d2587eb	2022-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207724 application number: ANDA207724

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
260243	progesterone 100 MG Oral Capsule	PSN	4de0715d-a3b9-42fa-b4e4-6371151fd75c	13
312641	progesterone 200 MG Oral Capsule	PSN	4de0715d-a3b9-42fa-b4e4-6371151fd75c	13
260243	progesterone 100 MG Oral Capsule	SCD	4de0715d-a3b9-42fa-b4e4-6371151fd75c	13
312641	progesterone 200 MG Oral Capsule	SCD	4de0715d-a3b9-42fa-b4e4-6371151fd75c	13
260243	progesterone 100 MG Oral Capsule	PSN	42c84fec-e5eb-78f7-e063-6294a90a4c0e	3
260243	progesterone 100 MG Oral Capsule	PSN	f26af2f3-4d1c-408f-8aa0-adbd1729d965	3
312641	progesterone 200 MG Oral Capsule	PSN	42c84fec-e5eb-78f7-e063-6294a90a4c0e	3
260243	progesterone 100 MG Oral Capsule	SCD	42c84fec-e5eb-78f7-e063-6294a90a4c0e	3
260243	progesterone 100 MG Oral Capsule	SCD	f26af2f3-4d1c-408f-8aa0-adbd1729d965	3
312641	progesterone 200 MG Oral Capsule	SCD	42c84fec-e5eb-78f7-e063-6294a90a4c0e	3
260243	progesterone 100 MG Oral Capsule	PSN	19716042-8025-43a3-b26d-e0fd7d2587eb	2
312641	progesterone 200 MG Oral Capsule	PSN	19716042-8025-43a3-b26d-e0fd7d2587eb	2
260243	progesterone 100 MG Oral Capsule	SCD	19716042-8025-43a3-b26d-e0fd7d2587eb	2
312641	progesterone 200 MG Oral Capsule	SCD	19716042-8025-43a3-b26d-e0fd7d2587eb	2
260243	progesterone 100 MG Oral Capsule	PSN	d7619751-47b4-47c9-b716-e2a704b350c8	1
260243	progesterone 100 MG Oral Capsule	SCD	d7619751-47b4-47c9-b716-e2a704b350c8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-807-10	65162080710	100 CAPSULE in 1 BOTTLE (65162-807-10)	100 capsule	2017-09-11	0000-00-00	No	No	Current
65162-807-50	65162080750	500 CAPSULE in 1 BOTTLE (65162-807-50)	500 capsule	2017-09-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Progesterone Capsules 100 mg and 200 mg Rx only	AvKARE	2026-06-16	HUMAN PRESCRIPTION DRUG LABEL	4
Progesterone Capsules (progesterone, USP), 100 mg and 200 mg Rx only	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC	2026-02-24	HUMAN PRESCRIPTION DRUG LABEL	13
Progesterone Capsules (progesterone, USP), 100 mg and 200 mg Rx only	REMEDYREPACK INC.	2026-01-21	HUMAN PRESCRIPTION DRUG LABEL	1
Progesterone Capsules (progesterone, USP), 100 mg and 200 mg	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-10-12	HUMAN PRESCRIPTION DRUG LABEL	2
Progesterone Capsules (progesterone, USP), 100 mg and 200 mg	Bryant Ranch Prepack	2021-12-28	HUMAN PRESCRIPTION DRUG LABEL	4
Progesterone Capsules (progesterone, USP), 100 mg and 200 mg	A-S Medication Solutions	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	3