PROGESTERONE

Product NDC: 70095-136
11-digit product format: 700950136
Labeler code: 70095
Product ID: 70095-136_5232dd12-1767-7fa2-e063-6294a90a4e70
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Progesterone
Dosage form: INSERT
Route: VAGINAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA022057
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2026-04-27
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022057-001	ENDOMETRIN	PROGESTERONE	100MG	INSERT / VAGINAL	AB	RLD, RS	2007-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022057-001	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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL	AB	RLD, RS	2007-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL	AB	RLD, RS	2007-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL	AB	RLD, RS	2007-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022057-001	ENDOMETRIN	100MG	INSERT / VAGINAL		RLD, RS	2007-06-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022057-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022057-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022057-001	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022057-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022057-001	7300664	2019-11-17	U-856		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022057-001	7320800	2019-11-17	U-856		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022057-001	7393543	2019-11-17	U-880	Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022057-001	7300664	2019-11-17	U-856		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022057-001	7320800	2019-11-17	U-856		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022057-001	7393543	2019-11-17	U-880	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022057-001	7300664	2019-11-17	U-856		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022057-001	7320800	2019-11-17	U-856		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022057-001	7393543	2019-11-17	U-880	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022057-001	7300664	2019-11-17	U-856		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022057-001	7320800	2019-11-17	U-856		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022057-001	7393543	2019-11-17	U-880	Drug product	`ea99ee380514…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
725094	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
fcdde0d0-4329-4725-a76b-684f9d97fe95	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
70095-136-01	PROGESTERONE	1 in 1 BLISTER PACK	INSERT	1	3
70095-136-02	PROGESTERONE	21 in 1 CARTON	INSERT	21	3
70095-136-03	PROGESTERONE	1 in 1 CARTON	INSERT	1	3

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ENDOMETRIN	PROGESTERONE	Ferring Pharmaceuticals Inc.	2ba50fa9-b349-40cb-9a4b-1af8faa4ec09	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022057 application number: NDA022057
PROGESTERONE	PROGESTERONE	Sun Pharmaceutical Industries, Inc.	fcdde0d0-4329-4725-a76b-684f9d97fe95	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022057 application number: NDA022057 ndc (product): 70095-136

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
725094	progesterone 100 MG Vaginal Tablet	PSN	fcdde0d0-4329-4725-a76b-684f9d97fe95	3
725094	progesterone 100 MG Vaginal Insert	SCD	fcdde0d0-4329-4725-a76b-684f9d97fe95	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70095-136-01	70095013601	1 in 1 BLISTER PACK					Historical
70095-136-02	70095013602	21 in 1 CARTON					Historical
70095-136-03	70095013603	1 CARTON in 1 CARTON (70095-136-03) / 21 BLISTER PACK in 1 CARTON (70095-136-02) / 1 INSERT in 1 BLISTER PACK (70095-136-01)	1 carton	2026-04-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROGESTERONE - Sun Pharmaceutical Industries, Inc. \| Sever Pharma solutions	Sun Pharmaceutical Industries, Inc. \| Sever Pharma solutions	2026-05-19	HUMAN PRESCRIPTION DRUG LABEL	3