CERVIDIL

Product NDC: 55566-2800
11-digit product format: 555662800
Labeler code: 55566
Product ID: 55566-2800_e99e60a2-51eb-417e-b2c4-67d5df479ea7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DINOPROSTONE
Dosage form: INSERT
Route: VAGINAL
Labeler: Ferring Pharmaceuticals Inc.
Application: NDA020411
Marketing category: NDA
Marketing start: 1995-03-30
Substance: DINOPROSTONE
Active strength: 10 mg/241mg
Pharmacologic classes: Prostaglandin Analog [EPC], Prostaglandins [CS]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020411-001	CERVIDIL	DINOPROSTONE	10MG	INSERT, EXTENDED RELEASE / VAGINAL		RLD, RS	1995-03-30

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020411-001	CERVIDIL	10MG	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1995-03-30	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: CERVIDIL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DINOPROSTONE	10 mg/241mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K7Q1JQR04M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
597957	Internal RxNorm lookup
597959	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
f3bc9031-0620-4a50-b440-f661cadfeb1d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ec05fe7c-3d4a-04dc-e557-6592b22322f9	Product name	1	20150831
66f853e1-4ba2-ac23-4f5d-e914cffa20b6	Product name	1	20150828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55566-2800-0	CERVIDIL	10 mg in 1 POUCH	INSERT	10		10
55566-2800-1	CERVIDIL	1 in 1 CARTON	INSERT	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55566-2800-1	EA - Each	55566-2800	32d9ee4b-22fb-4ebe-b05b-6868d45ffa8a	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DINOPROSTONE	ACTIVE INGREDIENT	K7Q1JQR04M	CERVIDIL (DINOPROSTONE) INSERT [FERRING PHARMACEUTICALS INC.]	2
DINOPROSTONE	ACTIVE MOIETY	K7Q1JQR04M	CERVIDIL (DINOPROSTONE) INSERT [FERRING PHARMACEUTICALS INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CERVIDIL (DINOPROSTONE) INSERT [FERRING PHARMACEUTICALS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55566-2800	CERVIDIL (DINOPROSTONE) INSERT [FERRING PHARMACEUTICALS INC.]	10	Current NDC, Legacy NDC, 2 package rows	20230607_f3bc9031-0620-4a50-b440-f661cadfeb1d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CERVIDIL	DINOPROSTONE	Ferring Pharmaceuticals Inc.	f3bc9031-0620-4a50-b440-f661cadfeb1d	2023-06-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020411 application number: NDA020411 ndc (product): 55566-2800

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K7Q1JQR04M	DINOPROSTONE	363-24-6	DINOPROSTONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
597959	Cervidil 10 MG Vaginal Insert	PSN	f3bc9031-0620-4a50-b440-f661cadfeb1d	10
597957	dinoprostone 10 MG Vaginal Insert	PSN	f3bc9031-0620-4a50-b440-f661cadfeb1d	10
597959	dinoprostone 10 MG Vaginal Insert [Cervidil]	SBD	f3bc9031-0620-4a50-b440-f661cadfeb1d	10
597957	dinoprostone 10 MG Vaginal Insert	SCD	f3bc9031-0620-4a50-b440-f661cadfeb1d	10
597959	Cervidil 10 MG Drug Implant	SY	f3bc9031-0620-4a50-b440-f661cadfeb1d	10
597959	Cervidil 10 MG Vaginal Insert	SY	f3bc9031-0620-4a50-b440-f661cadfeb1d	10
597957	PGE2 10 MG Vaginal Insert	SY	f3bc9031-0620-4a50-b440-f661cadfeb1d	10
597959	PGE2 10 MG Vaginal Insert [Cervidil]	SY	f3bc9031-0620-4a50-b440-f661cadfeb1d	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55566-2800-0	55566280000	10 mg in 1 POUCH	10 mg					Historical
55566-2800-1	55566280001	1 POUCH in 1 CARTON (55566-2800-1) / 10 mg in 1 POUCH (55566-2800-0)	1 pouch	1995-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CERVIDIL	Ferring Pharmaceuticals Inc. \| Ferring Controlled Therapeutics Ltd \| EUROAPI Hungary Ltd. \| Kyowa Pharma Chemical Co., Ltd.	2023-06-02	HUMAN PRESCRIPTION DRUG LABEL	10