Minivelle

Product NDC: 68968-6637
11-digit product format: 689686637
Labeler code: 68968
Product ID: 68968-6637_58e55d14-a9df-4814-9b60-b7c9ce37b0b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol
Dosage form: FILM, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Noven Therapeutics, LLC
Application: NDA203752
Marketing category: NDA
Marketing start: 2012-12-20
Substance: ESTRADIOL
Active strength: .0375 mg/d
Pharmacologic classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [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 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203752-001	MINIVELLE	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29
N203752-002	MINIVELLE	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29
N203752-003	MINIVELLE	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29
N203752-004	MINIVELLE	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29
N203752-005	MINIVELLE	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N203752-001	AB3
N203752-002	AB3
N203752-003	AB3
N203752-004	AB3
N203752-005	AB3

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203752-001	9730900	2028-07-10	U-2086		2017-08-18
N203752-001	9833419	2028-07-10		Drug product	2017-12-14
N203752-001	8231906	2030-07-04		Drug substance, Drug product	2013-03-22
N203752-002	9730900	2028-07-10	U-2086		2017-08-18
N203752-002	9833419	2028-07-10		Drug product	2017-12-14
N203752-002	8231906	2030-07-04		Drug substance, Drug product
N203752-003	9730900	2028-07-10	U-2086		2017-08-18
N203752-003	9833419	2028-07-10		Drug product	2017-12-14
N203752-003	8231906	2030-07-04		Drug substance, Drug product
N203752-004	9730900	2028-07-10	U-2086		2017-08-18
N203752-004	9833419	2028-07-10		Drug product	2017-12-14
N203752-004	8231906	2030-07-04		Drug substance, Drug product
N203752-005	9724310	2028-07-10		Drug substance, Drug product	2017-08-18
N203752-005	9730900	2028-07-10	U-2086	Drug product	2017-08-18
N203752-005	9833419	2028-07-10		Drug product	2017-12-14
N203752-005	8231906	2030-07-04		Drug substance, Drug product	2015-05-08

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 6 · 210 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	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	N203752-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-002	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-003	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-004	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-005	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203752-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-002	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-003	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-004	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-005	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-002	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-003	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-004	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-005	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203752-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203752-002	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203752-003	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203752-004	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203752-005	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-002	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-003	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-004	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-005	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-002	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-003	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-004	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-005	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-002	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-003	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-004	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-005	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-002	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-003	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-004	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-005	AB3	1	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 702 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N203752-001	9730900	2028-07-10	U-2086		2017-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-001	9833419	2028-07-10		Drug product	2017-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-001	8231906	2030-07-04		Drug substance, Drug product	2013-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-002	9730900	2028-07-10	U-2086		2017-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-002	9833419	2028-07-10		Drug product	2017-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-002	8231906	2030-07-04		Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-003	9730900	2028-07-10	U-2086		2017-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-003	9833419	2028-07-10		Drug product	2017-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-003	8231906	2030-07-04		Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-004	9730900	2028-07-10	U-2086		2017-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-004	9833419	2028-07-10		Drug product	2017-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-004	8231906	2030-07-04		Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-005	9724310	2028-07-10		Drug substance, Drug product	2017-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-005	9730900	2028-07-10	U-2086	Drug product	2017-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-005	9833419	2028-07-10		Drug product	2017-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-005	8231906	2030-07-04		Drug substance, Drug product	2015-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203752-001	9730900	2028-07-10	U-2086		2017-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-001	9833419	2028-07-10		Drug product	2017-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-001	8231906	2030-07-04		Drug substance, Drug product	2013-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-002	9730900	2028-07-10	U-2086		2017-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-002	9833419	2028-07-10		Drug product	2017-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-002	8231906	2030-07-04		Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-003	9730900	2028-07-10	U-2086		2017-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-003	9833419	2028-07-10		Drug product	2017-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-003	8231906	2030-07-04		Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-004	9730900	2028-07-10	U-2086		2017-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-004	9833419	2028-07-10		Drug product	2017-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-004	8231906	2030-07-04		Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-005	9724310	2028-07-10		Drug substance, Drug product	2017-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-005	9730900	2028-07-10	U-2086	Drug product	2017-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-005	9833419	2028-07-10		Drug product	2017-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-005	8231906	2030-07-04		Drug substance, Drug product	2015-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-001	9730900	2028-07-10	U-2086		2017-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-001	9833419	2028-07-10		Drug product	2017-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-001	8231906	2030-07-04		Drug substance, Drug product	2013-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-002	9730900	2028-07-10	U-2086		2017-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-002	9833419	2028-07-10		Drug product	2017-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-002	8231906	2030-07-04		Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-003	9730900	2028-07-10	U-2086		2017-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-003	9833419	2028-07-10		Drug product	2017-12-14	`31067a03dcf5…`

Additional Listing Data#

Finished product: Yes
Brand name base: Minivelle
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRADIOL	.0375 mg/d

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4TI98Z838E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
241946	Internal RxNorm lookup
242891	Internal RxNorm lookup
242892	Internal RxNorm lookup
248478	Internal RxNorm lookup
1149632	Internal RxNorm lookup
1356979	Internal RxNorm lookup
1356997	Internal RxNorm lookup
1357007	Internal RxNorm lookup
1357009	Internal RxNorm lookup
1551622	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
6c5c47ab-28ee-11e1-bfc2-0800200c9a66	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379	Product name	2	20250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6	Product name	2	20250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1	Product name	6	20250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbf	Product name	2	20250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1	Product name	3	20240507
66263a7f-f64d-41c4-90f1-2cee106617cc	Product name	1	20240501
76820076-f087-4073-b1d1-aa04b361335e	Product name	2	20220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94	Product name	3	20220126
0a040ba8-1f34-4328-bb07-4f64503daaab	Product name	2	20210513
833edb59-a012-45c2-aff5-2ed74b66fa59	Product name	1	20201207
f4d31098-441e-52d3-27f1-49c829f8a3a1	Product name	5	20190703
001f367b-fa14-49a0-865b-b395f2553601	Product name	2	20190611
3f090665-4687-4bb4-8790-8efb1930ee74	Product name	1	20180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4	Product name	1	20160623
3ca8d96e-517a-05ea-5690-f8e1d3726540	Product name	1	20140508
5f44c957-835a-ada0-662f-5b1071b7a68b	Product name	1	20140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183	Product name	1	20140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4	Product name	1	20140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4	Product name	1	20140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68968-6637-8	Minivelle	8 in 1 PACKET	FILM, EXTENDED RELEASE	8		19
68968-6637-8	Minivelle	1 d in 1 POUCH	FILM, EXTENDED RELEASE	1		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68968-6637-1	EA - Each	68968-6637	7720af54-e999-4121-9e44-39d784d83dd2	1	2015-11-12
68968-6637-8	EA - Each	68968-6637	f2091cb8-c18d-4cad-a1d7-559d8db330bd	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESTRADIOL	ACTIVE INGREDIENT	4TI98Z838E	MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	4
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	4
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	4
OLEYL ALCOHOL	INACTIVE INGREDIENT	172F2WN8DV	MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68968-6637	MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	19	Current NDC, Legacy NDC, 2 package rows	20240224_6c5c47ab-28ee-11e1-bfc2-0800200c9a66.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minivelle	ESTRADIOL	Noven Therapeutics, LLC	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203752 application number: NDA203752 ndc (product): 68968-6637
Estradiol	ESTRADIOL	A-S Medication Solutions	13f9c41b-417c-45e4-9a59-baf774fca78d	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203752 application number: NDA203752
Estradiol	ESTRADIOL	Noven Therapeutics, LLC	bf185599-2138-4083-9c52-2b95dce09ae0	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203752 application number: NDA203752

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4TI98Z838E	ESTRADIOL	50-28-2	ESTRADIOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
248478	estradiol 0.025 MG/Day Twice Weekly Transdermal System	PSN	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
241946	estradiol 0.0375 MG/Day Twice Weekly Transdermal System	PSN	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
242891	estradiol 0.05 MG/Day Twice Weekly Transdermal System	PSN	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1149632	estradiol 0.075 MG/Day Twice Weekly Transdermal System	PSN	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
242892	estradiol 0.1 MG/Day Twice Weekly Transdermal System	PSN	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1551622	Minivelle 0.025 MG/Day Twice Weekly Transdermal System	PSN	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1356979	Minivelle 0.0375 MG/Day Twice Weekly Transdermal System	PSN	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1356997	Minivelle 0.05 MG/Day Twice Weekly Transdermal System	PSN	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1357007	Minivelle 0.075 MG/Day Twice Weekly Transdermal System	PSN	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1357009	Minivelle 0.1 MG/Day Twice Weekly Transdermal System	PSN	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1551622	84 HR estradiol 0.00104 MG/HR Transdermal System [Minivelle]	SBD	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1356979	84 HR estradiol 0.00156 MG/HR Transdermal System [Minivelle]	SBD	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1356997	84 HR estradiol 0.00208 MG/HR Transdermal System [Minivelle]	SBD	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1357007	84 HR estradiol 0.00313 MG/HR Transdermal System [Minivelle]	SBD	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1357009	84 HR estradiol 0.00417 MG/HR Transdermal System [Minivelle]	SBD	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
248478	84 HR estradiol 0.00104 MG/HR Transdermal System	SCD	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
241946	84 HR estradiol 0.00156 MG/HR Transdermal System	SCD	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
242891	84 HR estradiol 0.00208 MG/HR Transdermal System	SCD	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1149632	84 HR estradiol 0.00313 MG/HR Transdermal System	SCD	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
242892	84 HR estradiol 0.00417 MG/HR Transdermal System	SCD	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1551622	84 HR Minivelle 0.00104 MG/HR Transdermal System	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1356979	84 HR Minivelle 0.00156 MG/HR Transdermal System	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1356997	84 HR Minivelle 0.00208 MG/HR Transdermal System	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1357007	84 HR Minivelle 0.00313 MG/HR Transdermal System	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1357009	84 HR Minivelle 0.00417 MG/HR Transdermal System	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
248478	estradiol 0.00104 MG/HR 84 HR Transdermal Patch	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
241946	estradiol 0.00156 MG/HR 84 HR Transdermal Patch	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
242891	estradiol 0.00208 MG/HR 84 HR Transdermal Patch	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1149632	estradiol 0.00313 MG/HR 84 HR Transdermal Patch	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
242892	estradiol 0.00417 MG/HR 84 HR Transdermal Patch	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
248478	estradiol 0.025 MG/Day Twice Weekly Transdermal Patch	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
248478	estradiol 0.025 MG/Day Twice Weekly Transdermal System	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
241946	estradiol 0.0375 MG/Day Twice Weekly Transdermal System	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
242891	estradiol 0.05 MG/Day Twice Weekly Transdermal System	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1149632	estradiol 0.075 MG/Day Twice Weekly Transdermal System	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
242892	estradiol 0.1 MG/24HR Twice Weekly Transdermal Patch	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
242892	estradiol 0.1 MG/Day Twice Weekly Transdermal System	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
241946	estradiol 37.5 MCG/Day Twice Weekly Transdermal Patch	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
242891	estradiol 50 MCG/Day Twice Weekly Transdermal Patch	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1149632	estradiol 75 MCG/Day Twice Weekly Transdermal Patch	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1551622	Minivelle 0.00104 MG/HR 84 HR Transdermal Patch	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1551622	Minivelle 0.025 MG per 24 HR Twice Weekly Transdermal Patch	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1551622	Minivelle 0.025 MG/Day Twice Weekly Transdermal System	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1356979	Minivelle 0.0375 MG per 24HR Twice Weekly Transdermal Patch	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1356979	Minivelle 0.0375 MG/Day Twice Weekly Transdermal System	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1356997	Minivelle 0.05 MG per 24HR Twice Weekly Transdermal Patch	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1356997	Minivelle 0.05 MG/Day Twice Weekly Transdermal System	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1357007	Minivelle 0.075 MG per 24HR Twice Weekly Transdermal Patch	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1357007	Minivelle 0.075 MG/Day Twice Weekly Transdermal System	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1357009	Minivelle 0.1 MG per 24HR Twice Weekly Transdermal Patch	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19
1357009	Minivelle 0.1 MG/Day Twice Weekly Transdermal System	SY	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68968-6637-8	68968663708	8 POUCH in 1 PACKET (68968-6637-8) / 1 d in 1 POUCH	8 pouch	2012-12-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Minivelle - Noven Therapeutics, LLC \| Noven Pharmaceuticals, Inc.	Noven Therapeutics, LLC \| Noven Pharmaceuticals, Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	20
Sharp Corporation blanket no changes certification of product listing	Sharp Corporation	2017-10-12	BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING	1