PROGESTERONE

Product NDC: 76420-580
Requested package NDC: 76420-580-10
11-digit product format: 764200580
Labeler code: 76420
Product ID: 76420-580_3485f152-22bd-e5bd-e063-6394a90afa5b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROGESTERONE
Dosage form: CAPSULE
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA200900
Marketing category: ANDA
Marketing start: 2018-11-28
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
A200900-001	PROGESTERONE	PROGESTERONE	100MG	CAPSULE / ORAL	AB		2013-08-16
A200900-002	PROGESTERONE	PROGESTERONE	200MG	CAPSULE / ORAL	AB		2013-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200900-001	AB
A200900-002	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	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`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	A200900-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200900-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200900-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200900-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200900-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200900-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200900-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200900-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200900-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200900-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200900-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200900-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200900-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200900-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200900-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200900-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200900-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200900-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200900-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200900-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200900-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200900-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200900-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200900-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200900-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200900-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200900-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200900-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200900-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200900-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200900-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200900-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200900-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200900-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200900-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200900-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200900-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200900-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200900-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200900-002	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 · 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
342a096d-df6f-47de-bdd1-ec259638e476	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	SPL version
76420-580-10	PROGESTERONE	100 in 1 BOTTLE	CAPSULE	100	2
76420-580-30	PROGESTERONE	30 in 1 BOTTLE	CAPSULE	30	2
76420-580-60	PROGESTERONE	60 in 1 BOTTLE	CAPSULE	60	2
76420-580-90	PROGESTERONE	90 in 1 BOTTLE	CAPSULE	90	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-580	PROGESTERONE CAPSULE [ASCLEMED USA, INC.]	2	Current NDC, 4 package rows	20250508_342a096d-df6f-47de-bdd1-ec259638e476.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROGESTERONE	PROGESTERONE	Golden State Medical Supply, Inc.	312db3af-9dd2-d5e4-e063-6394a90af999	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Bionpharma Inc.	41b3c3a7-5fb8-4451-a96c-2bd02613c021	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	A-S Medication Solutions	566584fc-c76a-4e42-a62e-109a2903b939	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Proficient Rx LP	199c8575-e113-468f-8eb7-c4930030649c	2026-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Bryant Ranch Prepack	46d97ca6-970f-478f-81ff-1b9a9f6cb2f7	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	NuCare Pharmaceuticals,Inc.	0b3da881-4720-cdee-e063-6394a90aee99	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	REMEDYREPACK INC.	947ebb7c-492b-4b83-aa1c-81e282df6421	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Preferred Pharmaceuticals Inc.	41c9546c-a854-4395-9506-d1be61f4e60f	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Preferred Pharmaceuticals Inc.	404e0b45-339b-4304-8e33-5f4ffe8f8e25	2025-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Bryant Ranch Prepack	0aeb0f0f-2749-416b-942f-83950200fd75	2025-05-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Asclemed USA, Inc.	342a096d-df6f-47de-bdd1-ec259638e476	2025-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900 ndc (package): 76420-580-10 ndc (product): 76420-580 ndc11 (package): 76420058010
PROGESTERONE	PROGESTERONE	NuCare Pharmaceuticals,Inc.	0d976866-81b3-5db8-e063-6294a90a39f9	2024-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Bionpharma Inc.	3acad9b0-7ec6-4d5e-9852-32ffadbbed6d	2018-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900

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	342a096d-df6f-47de-bdd1-ec259638e476	2
312641	progesterone 200 MG Oral Capsule	PSN	342a096d-df6f-47de-bdd1-ec259638e476	2
260243	progesterone 100 MG Oral Capsule	SCD	342a096d-df6f-47de-bdd1-ec259638e476	2
312641	progesterone 200 MG Oral Capsule	SCD	342a096d-df6f-47de-bdd1-ec259638e476	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-580-10	76420058010	100 CAPSULE in 1 BOTTLE (76420-580-10)	100 capsule	2023-08-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROGESTERONE - Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-05-07	HUMAN PRESCRIPTION DRUG LABEL	2