norethindrone acetate and ethinyl estradiol, and ferrous fumarate

Product NDC: 16714-155
11-digit product format: 167140155
Labeler code: 16714
Product ID: 16714-155_a5da4b36-69e5-3500-174c-952e0d771b15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: norethindrone acetate and ethinyl estradiol, and ferrous fumarate
Dosage form: KIT
Labeler: Northstar Rx LLC
Application: ANDA213317
Marketing category: ANDA
Marketing start: 2021-04-07
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2022-12-31
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	16714-155		D	Discontinued by firm		2026-08-03
excluded package	package	16714-155	16714-155-03	D	Discontinued by firm		2026-08-03

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
A213317-001	GEMMILY	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	CAPSULE / ORAL	AB		2020-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213317-001	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
2026-02-19 14:30 UTC	2026-02	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213317-001	GEMMILY	0.02MG;1MG	CAPSULE / ORAL	AB	2020-11-09	`a50c72e98297…`

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	A213317-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213317-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213317-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213317-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213317-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213317-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213317-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213317-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213317-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213317-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213317-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213317-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213317-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213317-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213317-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213317-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213317-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213317-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213317-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213317-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213317-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213317-001	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213317-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213317-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213317-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213317-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213317-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213317-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213317-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213317-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213317-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213317-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213317-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213317-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213317-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213317-001	AB	1	`a50c72e98297…`

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
Gemmily	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE	Xiromed, LLC	6ca786fb-8f28-d2ac-5d8d-a14c3af6d7a7	2023-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213317 application number: ANDA213317

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-155-01	EA - Each	16714-155	88228dd4-5f56-423c-949f-eedee63b1f0c	1	2021-05-05
16714-155-03	EA - Each	16714-155	2627861a-fa18-4bb3-906e-7771d1a06132	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-155	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE KIT [NORTHSTAR RX LLC]	5	Legacy NDC	20240210_e2199545-6b84-0c9a-80db-42bf3c204d85.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-155-03	16714015503	3 CARTON in 1 CARTON (16714-155-03) > 1 BLISTER PACK in 1 CARTON (16714-155-01) > 1 KIT in 1 BLISTER PACK	3 carton	2021-04-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
norethindrone acetate and ethinyl estradiol, and ferrous fumarate	Northstar Rx LLC \| Chemo Research, S.L. \| Patheon Softgels Inc.	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL	5