Vivelle-Dot

Product NDC: 0078-0365
Requested package NDC: 0078-0365-45
11-digit product format: 000780365
Labeler code: 0078
Product ID: 0078-0365_2740040f-a14a-4b53-83f7-842dd443081f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA020538
Marketing category: NDA
Marketing start: 1999-01-08
Marketing end: 0000-00-00
Substance: ESTRADIOL
Active strength: 0 mg/d
Pharmacologic classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0078-0365	0078-0365-45	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020538-005	VIVELLE-DOT	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08
N020538-006	VIVELLE-DOT	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08
N020538-007	VIVELLE-DOT	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08
N020538-008	VIVELLE-DOT	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08
N020538-009	VIVELLE-DOT	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020538-005	AB1
N020538-006	AB1
N020538-007	AB1
N020538-008	AB1
N020538-009	AB1

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 · 205 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
2026-02-19 14:30 UTC	2026-02	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	N020538-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020538-006	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020538-007	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020538-008	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020538-009	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-005	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-006	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-007	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-008	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-009	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020538-005	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020538-006	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020538-007	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020538-008	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020538-009	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-005	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-006	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-007	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-008	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-009	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-005	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-006	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-007	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-008	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-009	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020538-005	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020538-006	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020538-007	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020538-008	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020538-009	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020538-005	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020538-006	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020538-007	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020538-008	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020538-009	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020538-005	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020538-006	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020538-007	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020538-008	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020538-009	AB1	1	`5bbf6a4d5a75…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0365-42	EA - Each	0078-0365	89cf38af-765d-458b-93e3-d80aba552fd2	1	2012-07-24
0078-0365-45	EA - Each	0078-0365	cdd27ef6-4f6e-4a24-8a47-4ad4ba759cbd	1	2012-07-24
0078-0365-62	EA - Each	0078-0365	fddefc4d-4dd9-4ffc-8258-7baf5269bd5f	1	2016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESTRADIOL	ACTIVE INGREDIENT	4TI98Z838E	VIVELLE-DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	5
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	VIVELLE-DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	5
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	VIVELLE-DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	5
OLEYL ALCOHOL	INACTIVE INGREDIENT	172F2WN8DV	VIVELLE-DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	5
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	VIVELLE-DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	5
ESTRADIOL	ACTIVE INGREDIENT	4TI98Z838E	VIVELLE DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	VIVELLE DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	VIVELLE DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
OLEYL ALCOHOL	INACTIVE INGREDIENT	172F2WN8DV	VIVELLE DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	VIVELLE DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0365	VIVELLE-DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	14	Legacy NDC	20220712_e6f2e7ed-41a9-4a53-ac80-0cb1fa2edcbf.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
Estradiol	ESTRADIOL	Sandoz Inc	c4da6de7-9ab1-4fcf-88f3-fe785019e6e7	2024-02-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020538 application number: NDA020538
Vivelle-Dot	ESTRADIOL	Sandoz Inc	5ccb77f9-d47b-4381-ad5c-5b92524e1c4a	2023-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020538 application number: NDA020538

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	03ab0226-b494-4607-8e8b-7381082fa780	1
241946	estradiol 0.0375 MG/Day Twice Weekly Transdermal System	PSN	03ab0226-b494-4607-8e8b-7381082fa780	1
242891	estradiol 0.05 MG/Day Twice Weekly Transdermal System	PSN	03ab0226-b494-4607-8e8b-7381082fa780	1
1149632	estradiol 0.075 MG/Day Twice Weekly Transdermal System	PSN	03ab0226-b494-4607-8e8b-7381082fa780	1
242892	estradiol 0.1 MG/Day Twice Weekly Transdermal System	PSN	03ab0226-b494-4607-8e8b-7381082fa780	1
284378	Vivelle dot 0.025 MG/Day Twice Weekly Transdermal System	PSN	03ab0226-b494-4607-8e8b-7381082fa780	1
310172	Vivelle dot 0.0375 MG/Day Twice Weekly Transdermal System	PSN	03ab0226-b494-4607-8e8b-7381082fa780	1
310176	Vivelle dot 0.05 MG/Day Twice Weekly Transdermal System	PSN	03ab0226-b494-4607-8e8b-7381082fa780	1
1149634	Vivelle dot 0.075 MG/Day Twice Weekly Transdermal System	PSN	03ab0226-b494-4607-8e8b-7381082fa780	1
310183	Vivelle dot 0.1 MG/Day Twice Weekly Transdermal System	PSN	03ab0226-b494-4607-8e8b-7381082fa780	1
284378	84 HR estradiol 0.00104 MG/HR Transdermal System [Vivelle]	SBD	03ab0226-b494-4607-8e8b-7381082fa780	1
310172	84 HR estradiol 0.00156 MG/HR Transdermal System [Vivelle]	SBD	03ab0226-b494-4607-8e8b-7381082fa780	1
310176	84 HR estradiol 0.00208 MG/HR Transdermal System [Vivelle]	SBD	03ab0226-b494-4607-8e8b-7381082fa780	1
1149634	84 HR estradiol 0.00313 MG/HR Transdermal System [Vivelle]	SBD	03ab0226-b494-4607-8e8b-7381082fa780	1
310183	84 HR estradiol 0.00417 MG/HR Transdermal System [Vivelle]	SBD	03ab0226-b494-4607-8e8b-7381082fa780	1
248478	84 HR estradiol 0.00104 MG/HR Transdermal System	SCD	03ab0226-b494-4607-8e8b-7381082fa780	1
241946	84 HR estradiol 0.00156 MG/HR Transdermal System	SCD	03ab0226-b494-4607-8e8b-7381082fa780	1
242891	84 HR estradiol 0.00208 MG/HR Transdermal System	SCD	03ab0226-b494-4607-8e8b-7381082fa780	1
1149632	84 HR estradiol 0.00313 MG/HR Transdermal System	SCD	03ab0226-b494-4607-8e8b-7381082fa780	1
242892	84 HR estradiol 0.00417 MG/HR Transdermal System	SCD	03ab0226-b494-4607-8e8b-7381082fa780	1
284378	84 HR Vivelle 0.00104 MG/HR Transdermal System	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
310172	84 HR Vivelle 0.00156 MG/HR Transdermal System	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
310176	84 HR Vivelle 0.00208 MG/HR Transdermal System	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
1149634	84 HR Vivelle 0.00313 MG/HR Transdermal System	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
310183	84 HR Vivelle 0.00417 MG/HR Transdermal System	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
248478	estradiol 0.00104 MG/HR 84 HR Transdermal Patch	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
241946	estradiol 0.00156 MG/HR 84 HR Transdermal Patch	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
242891	estradiol 0.00208 MG/HR 84 HR Transdermal Patch	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
1149632	estradiol 0.00313 MG/HR 84 HR Transdermal Patch	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
242892	estradiol 0.00417 MG/HR 84 HR Transdermal Patch	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
248478	estradiol 0.025 MG/Day Twice Weekly Transdermal Patch	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
248478	estradiol 0.025 MG/Day Twice Weekly Transdermal System	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
241946	estradiol 0.0375 MG/Day Twice Weekly Transdermal System	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
242891	estradiol 0.05 MG/Day Twice Weekly Transdermal System	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
1149632	estradiol 0.075 MG/Day Twice Weekly Transdermal System	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
242892	estradiol 0.1 MG/24HR Twice Weekly Transdermal Patch	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
242892	estradiol 0.1 MG/Day Twice Weekly Transdermal System	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
241946	estradiol 37.5 MCG/Day Twice Weekly Transdermal Patch	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
242891	estradiol 50 MCG/Day Twice Weekly Transdermal Patch	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
1149632	estradiol 75 MCG/Day Twice Weekly Transdermal Patch	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
284378	Vivelle 0.025 MG/24HR Twice Weekly Transdermal Patch	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
310183	Vivelle 0.1 MG/24HR Twice Weekly Transdermal Patch	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
284378	Vivelle dot 0.025 MG/Day Twice Weekly Transdermal System	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
310172	Vivelle dot 0.0375 MG/24HR Twice Weekly Transdermal Patch	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
310172	Vivelle dot 0.0375 MG/Day Twice Weekly Transdermal System	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
310176	Vivelle Dot 0.05 MG/24HR Twice Weekly Transdermal Patch	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
310176	Vivelle dot 0.05 MG/Day Twice Weekly Transdermal System	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
1149634	Vivelle Dot 0.075 MG/24HR Twice Weekly Transdermal Patch	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
1149634	Vivelle dot 0.075 MG/Day Twice Weekly Transdermal System	SY	03ab0226-b494-4607-8e8b-7381082fa780	1
310183	Vivelle dot 0.1 MG/Day Twice Weekly Transdermal System	SY	03ab0226-b494-4607-8e8b-7381082fa780	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0365-45	00078036545	3 BOX in 1 CARTON (0078-0365-45) > 8 POUCH in 1 BOX > 1 PATCH in 1 POUCH > 3.5 d in 1 PATCH	3 box	1999-01-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vivelle-Dot - Novartis Pharmaceuticals Corporation	Novartis Pharmaceuticals Corporation	2022-07-11	HUMAN PRESCRIPTION DRUG LABEL	14
Vivelle-Dot	Physicians Total Care, Inc.	2012-02-17	HUMAN PRESCRIPTION DRUG LABEL	1