Norelgestromin and Ethinly Estradiol

Product NDC: 69238-1521
11-digit product format: 692381521
Labeler code: 69238
Product ID: 69238-1521_0a63a330-c4d1-4fb0-8e11-10b2971f1a57
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Norelgestromin and Ethinly Estradiol
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA213950
Marketing category: ANDA
Marketing start: 2021-02-26
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 43.

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
A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	ETHINYL ESTRADIOL; NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2021-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213950-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	BX	2021-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	BX	2021-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	BX	2021-02-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	BX	2021-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	BX	2021-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	BX	2021-02-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213950-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213950-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213950-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213950-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213950-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213950-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213950-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213950-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213950-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213950-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213950-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213950-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213950-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213950-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213950-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213950-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213950-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213950-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213950-001	BX	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213950-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213950-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213950-001	AB	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213950-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213950-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213950-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213950-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213950-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213950-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213950-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213950-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213950-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213950-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213950-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213950-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213950-001	BX	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213950-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A213950-001	CGT	2021-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213950-001	CGT	2021-08-25	`87673890dc5c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Norelgestromin and Ethinly Estradiol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NORELGESTROMIN	150 ug/d
ETHINYL ESTRADIOL	35 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1534809	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
36445b6a-e0f2-42f7-a8f3-5b80c90b87dd	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
69238-1521-1	Norelgestromin and Ethinly Estradiol	7 d in 1 PATCH	PATCH	7	9
69238-1521-1	Norelgestromin and Ethinly Estradiol	1 in 1 POUCH	PATCH	1	9
69238-1521-3	Norelgestromin and Ethinly Estradiol	3 in 1 CARTON	PATCH	3	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1521	NORELGESTROMIN AND ETHINLY ESTRADIOL PATCH [AMNEAL PHARMACEUTICALS NY LLC]	9	Current NDC, Legacy NDC, 3 package rows	20231231_36445b6a-e0f2-42f7-a8f3-5b80c90b87dd.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZAFEMY	NORELGESTROMIN AND ETHINYL ESTRADIOL	AvKARE	fbbd12dd-c538-2869-e053-6294a90a1a38	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213950 application number: ANDA213950
ZAFEMY	NORELGESTROMIN AND ETHINYL ESTRADIOL	Bryant Ranch Prepack	77230a20-4269-4abf-ae2a-ac5ccafef565	2024-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213950 application number: ANDA213950
ZAFEMY	NORELGESTROMIN AND ETHINYL ESTRADIOL	Amneal Pharmaceuticals LLC	5ee34c07-65af-42b8-a98f-e299ff90a8a1	2022-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213950 application number: ANDA213950
Norelgestromin and Ethinly Estradiol	NORELGESTROMIN AND ETHINLY ESTRADIOL	Amneal Pharmaceuticals NY LLC	36445b6a-e0f2-42f7-a8f3-5b80c90b87dd	2022-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213950 application number: ANDA213950 ndc (product): 69238-1521

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	36445b6a-e0f2-42f7-a8f3-5b80c90b87dd	9
1534809	168 HR ethinyl estradiol 0.00146 MG/HR / norelgestromin 0.00625 MG/HR Transdermal System	SCD	36445b6a-e0f2-42f7-a8f3-5b80c90b87dd	9
1534809	ethinyl estradiol 35 MCG / norelgestromin 150 MCG per 24HR 7 Day Transdermal Patch	SY	36445b6a-e0f2-42f7-a8f3-5b80c90b87dd	9
1534809	norelgestromin 150 MCG / ethinyl estradiol 35 MCG/Day Weekly Transdermal System	SY	36445b6a-e0f2-42f7-a8f3-5b80c90b87dd	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1521-1	69238152101	7 d in 1 PATCH	7 d					Historical
69238-1521-3	69238152103	3 POUCH in 1 CARTON (69238-1521-3) / 1 PATCH in 1 POUCH (69238-1521-1) / 7 d in 1 PATCH	3 pouch	2021-02-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NORELGESTROMIN - Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals, LLC	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals, LLC	2022-03-30	HUMAN PRESCRIPTION DRUG LABEL	9