XULANE

Product NDC: 0378-3340
11-digit product format: 003783340
Labeler code: 0378
Product ID: 0378-3340_5cf2e689-da68-4a6a-8761-267a63244360
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: norelgestromin and ethinyl estradiol
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA200910
Marketing category: ANDA
Marketing start: 2014-04-16
Substance: ETHINYL ESTRADIOL; NORELGESTROMIN
Active strength: 35; 150 ug/d; ug/d
Pharmacologic classes: Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [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 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
A200910-001	XULANE	ETHINYL ESTRADIOL; NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200910-001	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 · 41 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	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RS	2014-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RS	2014-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RS	2014-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RS	2014-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RS	2014-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RS	2014-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RS	2014-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200910-001	XULANE	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2014-04-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200910-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200910-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200910-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200910-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200910-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200910-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200910-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200910-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200910-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200910-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200910-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200910-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200910-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200910-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200910-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200910-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200910-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A200910-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200910-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200910-001	AB	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200910-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200910-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200910-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200910-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200910-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200910-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200910-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200910-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200910-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200910-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200910-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200910-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200910-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A200910-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NORELGESTROMIN	35 ug/d
ETHINYL ESTRADIOL	150 ug/d

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R0TAY3X631	Internal UNII lookup
423D2T571U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1534809	Internal RxNorm lookup
1536586	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
f7848550-086a-43d8-8ae5-047f4b9e4382	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11	Product name	4	20250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621f	Product name	1	20250307
8511fc19-172b-4e1f-90ec-2f09c85b16de	Product name	2	20250116
d9a998ac-31a9-4391-9054-c30e50912603	Product name	2	20240829
782f1593-b73e-4d35-8017-647969d714d8	Product name	4	20240805
1a545a57-aed5-4b6e-b1f9-a93c26d50eff	Product name	1	20230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50	Product name	3	20230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689	Product name	5	20230627
0d9f32e2-f85b-4d63-9f04-b06059c34749	Product name	3	20230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5	Product name	3	20210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9	Product name	3	20210513
cec4644c-0fed-4608-a5ea-d3a1b1b6d697	Product name	2	20200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424	Product name	6	20200716
5956a0e2-c373-452c-bdcf-c93d354432ef	Product name	1	20200714
ca306105-d51c-4821-9ec1-8eec753d073d	Product name	1	20200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9	Product name	8	20200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6	Product name	8	20191120
6dd982ab-2966-22ee-3b75-d225abb791aa	Product name	5	20190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4d	Product name	7	20190612
f92411e4-13dd-7baf-106e-9b3fcf758c39	Product name	4	20190502
60ff9adc-7870-42ca-8836-514bd9732fa8	Product name	4	20181220
ddff2484-d547-4e6a-bacd-95eef7e31c64	Product name	2	20180807
c6636356-4ccb-40e9-a952-59eb1f2fc859	Product name	4	20180806
79d5025d-8129-440a-b861-6df2d2661609	Product name	3	20180607
e042bc86-5d40-8945-82f8-de9dd95420dd	Product name	6	20180606
d871c48c-6b0b-4203-b55d-72ead21ea7ad	Product name	5	20180419
90854981-3820-4bc4-a1d3-666ec508941c	Product name	2	20180214
390e6d23-3a11-4327-9294-c958a378baae	Product name	4	20180124
12434b90-2738-45d5-9e1b-55001e853273	Product name	2	20171122
b651f154-0364-4007-9dc6-9d33036db1d7	Product name	4	20170808
3395ac9b-f30b-4991-80ba-fd5196be0214	Product name	3	20170802
2d386545-84d1-e1e9-1402-7fc8962353e8	Product name	2	20170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19	Product name	6	20170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8	Product name	4	20170608
00606b81-6e33-4c38-9ca9-bd14bd74d84c	Product name	4	20170501
f4ce24e8-8632-4fad-9984-b693f985f80f	Product name	3	20170501
b17c5419-b38b-579f-10bc-8a4ce69fc044	Product name	5	20170316
120cc5ad-761c-444c-9e82-dec22f96dfe1	Product name	7	20161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0c	Product name	1	20160714
2aecf0b6-88a0-49e5-92e1-983c700c116c	Product name	1	20151222
61972742-5d4d-491d-a881-b6bc3a011577	Product name	1	20151113
5e13e814-349e-3480-99f3-ee22a591426f	Product name	2	20150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508
d0cc7d42-77a7-b452-c6c3-a162fa11225f	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0378-3340-16	XULANE	7 d in 1 PATCH	PATCH	7	16
0378-3340-16	XULANE	1 in 1 POUCH	PATCH	1	16
0378-3340-17	XULANE	1 in 1 POUCH	PATCH	1	16
0378-3340-17	XULANE	7 d in 1 PATCH	PATCH	7	16
0378-3340-32	XULANE	1 in 1 CARTON	PATCH	1	16
0378-3340-53	XULANE	3 in 1 CARTON	PATCH	3	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-3340-16	EA - Each	0378-3340	29a3b2df-d582-4788-94c0-84f1ce211507	1	2017-06-15
0378-3340-53	EA - Each	0378-3340	fa993b2c-a314-4ad5-96f0-406dec3d5dc2	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETHINYL ESTRADIOL	ACTIVE INGREDIENT	423D2T571U	XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]	2
NORELGESTROMIN	ACTIVE INGREDIENT	R0TAY3X631	XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]	2
ETHINYL ESTRADIOL	ACTIVE MOIETY	423D2T571U	XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]	2
NORELGESTROMIN	ACTIVE MOIETY	R0TAY3X631	XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]	2
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]	2
OLEYL ALCOHOL	INACTIVE INGREDIENT	172F2WN8DV	XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-3340	XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]	16	Current NDC, Legacy NDC, 6 package rows	20220505_f7848550-086a-43d8-8ae5-047f4b9e4382.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
XULANE	NORELGESTROMIN AND ETHINYL ESTRADIOL	A-S Medication Solutions	adcf17ef-e60b-48a4-9478-3998dab2bbbd	2024-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200910 application number: ANDA200910
XULANE	NORELGESTROMIN AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	f7848550-086a-43d8-8ae5-047f4b9e4382	2022-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200910 application number: ANDA200910 ndc (product): 0378-3340

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
423D2T571U	ETHINYL ESTRADIOL	57-63-6	ETHINYL ESTRADIOL
R0TAY3X631	NORELGESTROMIN	53016-31-2	NORELGESTROMIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1534809	norelgestromin 150 MCG / ethinyl estradiol 35 MCG/Day Weekly Transdermal System	PSN	f7848550-086a-43d8-8ae5-047f4b9e4382	16
1536586	Xulane 150/35 MCG/Day Weekly Transdermal System	PSN	f7848550-086a-43d8-8ae5-047f4b9e4382	16
1536586	168 HR ethinyl estradiol 0.00146 MG/HR / norelgestromin 0.00625 MG/HR Transdermal System [Xulane]	SBD	f7848550-086a-43d8-8ae5-047f4b9e4382	16
1534809	168 HR ethinyl estradiol 0.00146 MG/HR / norelgestromin 0.00625 MG/HR Transdermal System	SCD	f7848550-086a-43d8-8ae5-047f4b9e4382	16
1534809	ethinyl estradiol 35 MCG / norelgestromin 150 MCG per 24HR 7 Day Transdermal Patch	SY	f7848550-086a-43d8-8ae5-047f4b9e4382	16
1534809	norelgestromin 150 MCG / ethinyl estradiol 35 MCG/Day Weekly Transdermal System	SY	f7848550-086a-43d8-8ae5-047f4b9e4382	16
1536586	Xulane (ethinyl estradiol 35 MCG / norelgestromin 150 MCG per 24HR) 7 Day Transdermal Patch	SY	f7848550-086a-43d8-8ae5-047f4b9e4382	16
1536586	Xulane 150/35 MCG/Day Weekly Transdermal System	SY	f7848550-086a-43d8-8ae5-047f4b9e4382	16
1534809	norelgestromin 150 MCG / ethinyl estradiol 35 MCG/Day Weekly Transdermal System	PSN	adcf17ef-e60b-48a4-9478-3998dab2bbbd	15
1536586	Xulane 150/35 MCG/Day Weekly Transdermal System	PSN	adcf17ef-e60b-48a4-9478-3998dab2bbbd	15
1536586	168 HR ethinyl estradiol 0.00146 MG/HR / norelgestromin 0.00625 MG/HR Transdermal System [Xulane]	SBD	adcf17ef-e60b-48a4-9478-3998dab2bbbd	15
1534809	168 HR ethinyl estradiol 0.00146 MG/HR / norelgestromin 0.00625 MG/HR Transdermal System	SCD	adcf17ef-e60b-48a4-9478-3998dab2bbbd	15
1534809	ethinyl estradiol 35 MCG / norelgestromin 150 MCG per 24HR 7 Day Transdermal Patch	SY	adcf17ef-e60b-48a4-9478-3998dab2bbbd	15
1534809	norelgestromin 150 MCG / ethinyl estradiol 35 MCG/Day Weekly Transdermal System	SY	adcf17ef-e60b-48a4-9478-3998dab2bbbd	15
1536586	Xulane (ethinyl estradiol 35 MCG / norelgestromin 150 MCG per 24HR) 7 Day Transdermal Patch	SY	adcf17ef-e60b-48a4-9478-3998dab2bbbd	15
1536586	Xulane 150/35 MCG/Day Weekly Transdermal System	SY	adcf17ef-e60b-48a4-9478-3998dab2bbbd	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-3340-16	00378334016	7 d in 1 PATCH	7 d					Historical
0378-3340-17	00378334017	1 in 1 POUCH						Historical
0378-3340-32	00378334032	1 POUCH in 1 CARTON (0378-3340-32) / 1 PATCH in 1 POUCH (0378-3340-17) / 7 d in 1 PATCH	1 pouch	2016-06-13	0000-00-00	Yes	No	Current
0378-3340-53	00378334053	3 POUCH in 1 CARTON (0378-3340-53) / 1 PATCH in 1 POUCH (0378-3340-16) / 7 d in 1 PATCH	3 pouch	2014-04-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XULANE - A-S Medication Solutions	A-S Medication Solutions	2024-02-27	HUMAN PRESCRIPTION DRUG LABEL	15
XULANE - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2022-03-04	HUMAN PRESCRIPTION DRUG LABEL	17