LOPREEZA

Product NDC: 69238-1609
Requested package NDC: 69238-1609-6
11-digit product format: 692381609
Labeler code: 69238
Product ID: 69238-1609_617a2d78-e850-4965-a23a-b0eacd0541a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol/norethindrone acetate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: NDA020907
Marketing category: NDA
Marketing start: 2019-01-07
Substance: ESTRADIOL; NORETHINDRONE ACETATE
Active strength: .5; .1 mg/1; mg/1
Pharmacologic classes: Estradiol Congeners [CS], 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

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 · 5 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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ESTRADIOL; NORETHINDRONE ACETATE	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28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.

Additional Listing Data#

Finished product: Yes
Brand name base: LOPREEZA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRADIOL	.5 mg/1
NORETHINDRONE ACETATE	.1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9S44LIC7OJ	Internal UNII lookup
4TI98Z838E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1359123	Internal RxNorm lookup
1359124	Internal RxNorm lookup
1359126	Internal RxNorm lookup
1359127	Internal RxNorm lookup
1550964	Internal RxNorm lookup
1550965	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
966ac064-9eb7-4d15-b271-a7880ed1e79a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379	Product name	2	20250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6	Product name	2	20250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1	Product name	6	20250311
d39a542a-f5b0-4c2d-a820-0f5d39e6621f	Product name	1	20250307
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbf	Product name	2	20250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1	Product name	3	20240507
66263a7f-f64d-41c4-90f1-2cee106617cc	Product name	1	20240501
859c4b0b-8cba-4f41-9afe-cc181a01fb62	Product name	2	20240215
0d9f32e2-f85b-4d63-9f04-b06059c34749	Product name	3	20230323
76820076-f087-4073-b1d1-aa04b361335e	Product name	2	20220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94	Product name	3	20220126
0a040ba8-1f34-4328-bb07-4f64503daaab	Product name	2	20210513
833edb59-a012-45c2-aff5-2ed74b66fa59	Product name	1	20201207
cec4644c-0fed-4608-a5ea-d3a1b1b6d697	Product name	2	20200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424	Product name	6	20200716
f4d31098-441e-52d3-27f1-49c829f8a3a1	Product name	5	20190703
001f367b-fa14-49a0-865b-b395f2553601	Product name	2	20190611
c21bcd2e-ecbd-48e6-ab68-12cc12256c0f	Product name	2	20190213
c6636356-4ccb-40e9-a952-59eb1f2fc859	Product name	4	20180806
3f090665-4687-4bb4-8790-8efb1930ee74	Product name	1	20180801
e042bc86-5d40-8945-82f8-de9dd95420dd	Product name	6	20180606
390e6d23-3a11-4327-9294-c958a378baae	Product name	4	20180124
b651f154-0364-4007-9dc6-9d33036db1d7	Product name	4	20170808
3395ac9b-f30b-4991-80ba-fd5196be0214	Product name	3	20170802
a5e2d962-d98c-4fbf-8183-ffd42dd01e19	Product name	6	20170711
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
f6ac5560-6d3b-d281-41d2-adc50d283c20	Product name	3	20170228
01996782-abcb-4e6d-bcaf-4a23e6a95c0c	Product name	1	20160714
7a549f52-8b99-472c-8b1d-3a70c53c9bf4	Product name	1	20160623
2aecf0b6-88a0-49e5-92e1-983c700c116c	Product name	1	20151222
61972742-5d4d-491d-a881-b6bc3a011577	Product name	1	20151113
23ede539-308f-46e5-817b-41ef23af8d40	Product name	1	20150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4d	Product name	1	20150930
5e13e814-349e-3480-99f3-ee22a591426f	Product name	2	20150518
3ca8d96e-517a-05ea-5690-f8e1d3726540	Product name	1	20140508
5f44c957-835a-ada0-662f-5b1071b7a68b	Product name	1	20140508
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183	Product name	1	20140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4	Product name	1	20140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4	Product name	1	20140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69238-1609-6	LOPREEZA	28 in 1 BLISTER PACK	TABLET, FILM COATED	28		10
69238-1609-6	LOPREEZA	1 in 1 CARTON	TABLET, FILM COATED	1		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1609	LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]	10	Current NDC, Legacy NDC, 2 package rows	20250124_966ac064-9eb7-4d15-b271-a7880ed1e79a.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 · 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 ndc (package): 69238-1609-6 ndc (product): 69238-1609 ndc11 (package): 69238160906
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1550964	{28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } Pack [Lopreeza 0.5/0.1 28 Day]	BPCK	966ac064-9eb7-4d15-b271-a7880ed1e79a	10
1550965	{28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } Pack [Lopreeza 1/0.5 28 Day]	BPCK	966ac064-9eb7-4d15-b271-a7880ed1e79a	10
1359124	{28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } Pack	GPCK	966ac064-9eb7-4d15-b271-a7880ed1e79a	10
1359127	{28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } Pack	GPCK	966ac064-9eb7-4d15-b271-a7880ed1e79a	10
1359124	Estra-Noreth Ac 0.5-0.1 MG (28) Oral Tablet 28 Day Pack	PSN	966ac064-9eb7-4d15-b271-a7880ed1e79a	10
1359127	Estra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day Pack	PSN	966ac064-9eb7-4d15-b271-a7880ed1e79a	10
1359123	estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet	PSN	966ac064-9eb7-4d15-b271-a7880ed1e79a	10
1359126	estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet	PSN	966ac064-9eb7-4d15-b271-a7880ed1e79a	10
1550964	Lopreeza 0.5/0.1 28 Day Pack	PSN	966ac064-9eb7-4d15-b271-a7880ed1e79a	10
1550965	Lopreeza 1/0.5 28 Day Pack	PSN	966ac064-9eb7-4d15-b271-a7880ed1e79a	10
1359123	estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet	SCD	966ac064-9eb7-4d15-b271-a7880ed1e79a	10
1359126	estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet	SCD	966ac064-9eb7-4d15-b271-a7880ed1e79a	10
1550964	Lopreeza 0.5/0.1 28 Day Pack	SY	966ac064-9eb7-4d15-b271-a7880ed1e79a	10
1550965	Lopreeza 1/0.5 28 Day Pack	SY	966ac064-9eb7-4d15-b271-a7880ed1e79a	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69238-1609-6	69238160906	1 BLISTER PACK in 1 CARTON (69238-1609-6) / 28 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2019-01-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LOPREEZA	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals of New York, LLC	2025-01-16	HUMAN PRESCRIPTION DRUG LABEL	10