Layolis Fe

Product NDC: 52544-064
11-digit product format: 525440064
Labeler code: 52544
Product ID: 52544-064_5f54ff08-9e07-4085-9980-04895ba6826d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: norethindrone, ethinyl estradiol, and ferrous fumarate
Dosage form: KIT
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: NDA022573
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2011-12-23
Marketing end: 0000-00-00
Active strength: 0
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52544-064		D	Discontinued by firm		2026-08-17
excluded package	package	52544-064	52544-064-31	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE	0.025MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD	2010-12-22

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 · 42 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
2026-08-18 06:07:40	2026-07	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD	2010-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL		RLD	2010-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL		RLD	2010-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL		RLD	2010-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022573-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022573-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022573-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022573-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022573-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022573-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022573-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022573-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022573-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022573-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022573-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022573-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022573-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022573-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022573-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022573-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022573-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022573-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022573-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022573-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022573-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022573-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022573-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022573-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022573-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022573-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022573-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022573-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022573-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022573-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022573-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022573-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022573-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022573-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022573-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022573-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022573-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022573-001	6667050	2019-04-06	U-828	Drug product	2011-01-20	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022573-001	6667050	2019-04-06	U-828	Drug product	2011-01-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022573-001	6667050	2019-04-06	U-828	Drug product	2011-01-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022573-001	6667050	2019-04-06	U-828	Drug product	2011-01-20	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52544-064-31	EA - Each	52544-064	bf822132-fd3c-4a29-b22f-c751d77d817e	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETHINYL ESTRADIOL	ACTIVE INGREDIENT	423D2T571U	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2
NORETHINDRONE	ACTIVE INGREDIENT	T18F433X4S	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2
ETHINYL ESTRADIOL	ACTIVE MOIETY	423D2T571U	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2
NORETHINDRONE	ACTIVE MOIETY	T18F433X4S	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2
FERROUS FUMARATE	INACTIVE INGREDIENT	R5L488RY0Q	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2
SPEARMINT	INACTIVE INGREDIENT	J7I2T6IV1N	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52544-064	LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]	9	Legacy NDC	20240329_c0db84ca-b8d4-4ed2-b2f6-19347283146e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52544-064-31	52544006431	3 BLISTER PACK in 1 CARTON (52544-064-31) > 1 KIT in 1 BLISTER PACK	3 blister pack	2011-12-23	0000-00-00	No	No	Current