ENDOMETRIN

Product NDC: 55566-6500
11-digit product format: 555666500
Labeler code: 55566
Product ID: 55566-6500_036428ab-ccb8-450f-8509-ccea24452cd7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Progesterone
Dosage form: INSERT
Route: VAGINAL
Labeler: Ferring Pharmaceuticals Inc.
Application: NDA022057
Marketing category: NDA
Marketing start: 2007-06-21
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: ENDOMETRIN
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
725094	Internal RxNorm lookup
725098	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
2ba50fa9-b349-40cb-9a4b-1af8faa4ec09	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
b46148e2-ee15-98d5-12f0-f5ec8745f6fc	Product name	3	20220927
76820076-f087-4073-b1d1-aa04b361335e	Product name	2	20220921
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
d3229c1a-4e51-4e04-9b13-00d24fd35242	Product name	1	20200821
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
213f0591-95c1-b398-40b7-08b31f66b026	Product name	4	20190206
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
55566-6500-1	ENDOMETRIN	1 in 1 BLISTER PACK	INSERT	1	24
55566-6500-2	ENDOMETRIN	21 in 1 CARTON	INSERT	21	24
55566-6500-3	ENDOMETRIN	1 in 1 CARTON	INSERT	1	24
55566-6500-4	ENDOMETRIN	21 in 1 BLISTER PACK	INSERT	21	24
55566-6500-7	ENDOMETRIN	21 in 1 CARTON	INSERT	21	24
55566-6500-8	ENDOMETRIN	21 in 1 CARTON	INSERT	21	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55566-6500-1	EA - Each	55566-6500	d5bfa955-c304-4c23-8343-ff0c538da2de	1	2014-05-02
55566-6500-2	EA - Each	55566-6500	4275c563-b289-4c4b-aa34-20bf2af11a1e	1	2012-07-24
55566-6500-3	EA - Each	55566-6500	be904677-f734-410c-bfa1-9b3abdc28469	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Progesterone	ACTIVE INGREDIENT	4G7DS2Q64Y	ENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]	11
Progesterone	ACTIVE MOIETY	4G7DS2Q64Y	ENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]	11
Adipic Acid	INACTIVE INGREDIENT	76A0JE0FKJ	ENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]	11
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]	11
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	ENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]	11
Povidone K29/32	INACTIVE INGREDIENT	390RMW2PEQ	ENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]	11
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	ENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]	11
Sodium Bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	ENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]	11
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	ENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]	11
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	ENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55566-6500	ENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]	21	Current NDC, Legacy NDC, 6 package rows	20250410_2ba50fa9-b349-40cb-9a4b-1af8faa4ec09.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 · 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 ndc (product): 55566-6500
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

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
725098	Endometrin 100 MG Vaginal Insert	PSN	2ba50fa9-b349-40cb-9a4b-1af8faa4ec09	24
725094	progesterone 100 MG Vaginal Tablet	PSN	2ba50fa9-b349-40cb-9a4b-1af8faa4ec09	24
725098	progesterone 100 MG Vaginal Insert [Endometrin]	SBD	2ba50fa9-b349-40cb-9a4b-1af8faa4ec09	24
725094	progesterone 100 MG Vaginal Insert	SCD	2ba50fa9-b349-40cb-9a4b-1af8faa4ec09	24
725098	Endometrin 100 MG Vaginal Insert	SY	2ba50fa9-b349-40cb-9a4b-1af8faa4ec09	24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55566-6500-1	55566650001	1 in 1 BLISTER PACK						Historical
55566-6500-2	55566650002	21 in 1 CARTON						Historical
55566-6500-3	55566650003	1 CARTON in 1 CARTON (55566-6500-3) / 21 BLISTER PACK in 1 CARTON (55566-6500-2) / 1 INSERT in 1 BLISTER PACK (55566-6500-1)	1 carton	2007-06-21	0000-00-00	No	No	Current
55566-6500-4	55566650004	21 in 1 BLISTER PACK						Historical
55566-6500-7	55566650007	21 in 1 CARTON						Historical
55566-6500-8	55566650008	21 CARTON in 1 CARTON (55566-6500-8) / 21 BLISTER PACK in 1 CARTON (55566-6500-7) / 21 INSERT in 1 BLISTER PACK (55566-6500-4)	21 carton	2007-06-21		Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ENDOMETRIN - Ferring Pharmaceuticals Inc.	Ferring Pharmaceuticals Inc.	2026-07-29	HUMAN PRESCRIPTION DRUG LABEL	27