Activella

Product NDC: 60846-202
11-digit product format: 608460202
Labeler code: 60846
Product ID: 60846-202_a5109fb8-c0d8-4416-a795-3381b3831109
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol and norethindrone acetate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Gemini Laboratories, LLC
Application: NDA020907
Marketing category: NDA
Marketing start: 2016-05-12
Marketing end: 2020-07-31
Substance: ESTRADIOL; NORETHINDRONE ACETATE
Active strength: 1 mg/1; mg/1
Pharmacologic classes: Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	60846-202		D	Discontinued by firm		2026-10-02
excluded package	package	60846-202	60846-202-01	D	Discontinued by firm		2026-10-02

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60846-202-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60846-202-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60846-202-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60846-202-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60846-202-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60846-202-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60846-202-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60846-202-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60846-202-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60846-202-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60846-202-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60846-202-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020907-001	ACTIVELLA	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18
N020907-002	ACTIVELLA	ESTRADIOL; NORETHINDRONE ACETATE	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020907-001	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 3 · 86 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
2026-09-14 22:38:34	2026-08	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020907-002	ACTIVELLA	0.5MG;0.1MG	TABLET / ORAL		RLD	2006-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020907-002	ACTIVELLA	0.5MG;0.1MG	TABLET / ORAL		RLD	2006-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020907-002	ACTIVELLA	0.5MG;0.1MG	TABLET / ORAL		RLD	2006-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020907-002	ACTIVELLA	0.5MG;0.1MG	TABLET / ORAL	AB	RLD	2006-12-28	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 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	N020907-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020907-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020907-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020907-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020907-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020907-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020907-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020907-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020907-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020907-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020907-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020907-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020907-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020907-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020907-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020907-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020907-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020907-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020907-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020907-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020907-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020907-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020907-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020907-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020907-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020907-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020907-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020907-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020907-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020907-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020907-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020907-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020907-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020907-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020907-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020907-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020907-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020907-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020907-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020907-001	AB	1	`1c564ffb4f44…`

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
60846-202-01	EA - Each	60846-202	5f227670-79b2-49dc-9bb3-c0f1f0627c66	1	2016-06-14

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LOPREEZA	ESTRADIOL/NORETHINDRONE ACETATE	Amneal Pharmaceuticals NY LLC	966ac064-9eb7-4d15-b271-a7880ed1e79a	2025-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020907 application number: NDA020907
Activella	ESTRADIOL/NORETHINDRONE ACETATE	Amneal Pharmaceuticals LLC	d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0	2023-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020907 application number: NDA020907
Lopreeza	ESTRADIOL/NORETHINDRONE ACETATE	Amneal Pharmaceuticals NY LLC	bf0e39cb-95e7-4831-92d2-0b3f071aeaae	2017-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020907 application number: NDA020907

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4TI98Z838E	ESTRADIOL	50-28-2	ESTRADIOL
9S44LIC7OJ	NORETHINDRONE ACETATE	51-98-9	NORETHINDRONE ACETATE