Vivelle-Dot

Product NDC: 0078-0345
Requested package NDC: 0078-0345-45
11-digit product format: 000780345
Labeler code: 0078
Product ID: 0078-0345_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	0078-0345	0078-0345-45	D	Discontinued by firm		2026-11-06

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 44.

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 · 220 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
2026-10-15 13:18:30	2026-09	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N020538-005	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020538-006	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020538-007	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020538-008	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020538-009	AB1	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020538-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020538-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020538-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020538-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020538-009	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020538-005	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020538-006	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020538-007	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020538-008	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020538-009	AB1	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0078-0345-42	EA - Each	0078-0345	f2bcfa6c-8798-483f-9f6b-b4913af6e38a	1	2012-07-24
0078-0345-45	EA - Each	0078-0345	09a090fe-6837-42bb-9537-99311681d3ca	1	2012-07-24
0078-0345-62	EA - Each	0078-0345	fd7fe101-b92a-4718-b4ac-1cb1d9cad05d	1	2012-07-24

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
0078-0345	VIVELLE-DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	14	Legacy NDC	20220712_e6f2e7ed-41a9-4a53-ac80-0cb1fa2edcbf.zip

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
0078-0345-45	00078034545	3 BOX in 1 CARTON (0078-0345-45) > 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