NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Product NDC: 0378-7308
Requested package NDC: 0378-7308-53
11-digit product format: 003787308
Labeler code: 0378
Product ID: 0378-7308_dd233955-5be5-4025-a841-66378e261dd2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: norethindrone and ethinyl estradiol and ferrous fumarate
Dosage form: KIT
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA203371
Marketing category: ANDA
Marketing start: 2015-04-01
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2020-12-31
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	0378-7308	0378-7308-53	D	Discontinued by firm		2026-10-05

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
A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB		2014-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203371-001	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 · 43 observed 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	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203371-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	2014-04-23	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203371-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203371-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203371-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203371-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203371-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203371-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203371-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203371-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203371-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203371-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203371-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203371-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203371-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203371-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203371-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203371-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203371-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203371-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203371-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203371-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203371-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203371-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203371-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203371-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203371-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203371-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203371-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203371-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203371-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203371-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203371-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203371-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203371-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203371-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203371-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203371-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203371-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203371-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203371-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203371-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-7308-53	EA - Each	0378-7308	8c6816e6-2b70-49a5-b1f6-bc636b3673f9	1	2015-05-05
0378-7308-85	EA - Each	0378-7308	5afd1f5e-a7a2-470d-8951-213cea24a3dc	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETHINYL ESTRADIOL	ACTIVE INGREDIENT	423D2T571U	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
NORETHINDRONE	ACTIVE INGREDIENT	T18F433X4S	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
ETHINYL ESTRADIOL	ACTIVE MOIETY	423D2T571U	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
NORETHINDRONE	ACTIVE MOIETY	T18F433X4S	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
FERROUS FUMARATE	INACTIVE INGREDIENT	R5L488RY0Q	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
SPEARMINT	INACTIVE INGREDIENT	J7I2T6IV1N	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-7308	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE KIT [MYLAN PHARMACEUTICALS INC.]	6	Legacy NDC	20250523_c89388f0-ffe4-4058-a644-3f43fb4d021b.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GALBRIELA	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	Xiromed, LLC	47465e7e-64f2-690b-166e-0e1c3e5bec7a	2024-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203371 application number: ANDA203371

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-7308-53	00378730853	3 POUCH in 1 CARTON (0378-7308-53) > 1 KIT in 1 POUCH (0378-7308-85)	3 pouch	2015-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	Mylan Pharmaceuticals Inc.	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL	6