Nortrel 7/7/7

Product NDC: 0555-9012
11-digit product format: 005559012
Labeler code: 0555
Product ID: 0555-9012_5157d13b-a384-46cb-9e9e-f3691d4f9072
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Norethindrone and Ethinyl Estradiol
Dosage form: KIT
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA075478
Marketing category: ANDA
Marketing start: 2003-01-02
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A075478-001	NORTREL 7/7/7	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21			2002-08-30
A075478-002	NORTREL 7/7/7	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB		2002-08-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075478-002	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075478-001	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-21		2002-08-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075478-002	NORTREL 7/7/7	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET / ORAL-28	AB	2002-08-30	`74a2ff9319b5…`

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	A075478-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075478-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075478-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075478-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075478-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075478-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075478-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075478-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075478-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075478-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075478-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075478-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075478-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075478-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075478-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075478-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075478-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075478-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075478-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075478-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075478-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075478-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075478-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075478-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075478-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075478-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075478-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075478-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075478-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075478-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075478-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075478-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075478-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075478-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075478-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075478-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075478-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075478-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075478-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075478-002	AB	1	`f41ea6bd6efb…`

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: Nortrel 7/7/7
Brand name suffix: (28 Day Regimen)
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310463	Internal RxNorm lookup
312033	Internal RxNorm lookup
392662	Internal RxNorm lookup
748797	Internal RxNorm lookup
749852	Internal RxNorm lookup
762007	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
992dcc56-90ab-4691-8114-16d47a8b9982	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11	Product name	4	20250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621f	Product name	1	20250307
8511fc19-172b-4e1f-90ec-2f09c85b16de	Product name	2	20250116
d9a998ac-31a9-4391-9054-c30e50912603	Product name	2	20240829
782f1593-b73e-4d35-8017-647969d714d8	Product name	4	20240805
859c4b0b-8cba-4f41-9afe-cc181a01fb62	Product name	2	20240215
1a545a57-aed5-4b6e-b1f9-a93c26d50eff	Product name	1	20230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50	Product name	3	20230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689	Product name	5	20230627
0d9f32e2-f85b-4d63-9f04-b06059c34749	Product name	3	20230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5	Product name	3	20210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9	Product name	3	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
5956a0e2-c373-452c-bdcf-c93d354432ef	Product name	1	20200714
ca306105-d51c-4821-9ec1-8eec753d073d	Product name	1	20200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9	Product name	8	20200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6	Product name	8	20191120
f4d31098-441e-52d3-27f1-49c829f8a3a1	Product name	5	20190703
6dd982ab-2966-22ee-3b75-d225abb791aa	Product name	5	20190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4d	Product name	7	20190612
f92411e4-13dd-7baf-106e-9b3fcf758c39	Product name	4	20190502
c21bcd2e-ecbd-48e6-ab68-12cc12256c0f	Product name	2	20190213
60ff9adc-7870-42ca-8836-514bd9732fa8	Product name	4	20181220
ddff2484-d547-4e6a-bacd-95eef7e31c64	Product name	2	20180807
c6636356-4ccb-40e9-a952-59eb1f2fc859	Product name	4	20180806
79d5025d-8129-440a-b861-6df2d2661609	Product name	3	20180607
e042bc86-5d40-8945-82f8-de9dd95420dd	Product name	6	20180606
d871c48c-6b0b-4203-b55d-72ead21ea7ad	Product name	5	20180419
90854981-3820-4bc4-a1d3-666ec508941c	Product name	2	20180214
390e6d23-3a11-4327-9294-c958a378baae	Product name	4	20180124
12434b90-2738-45d5-9e1b-55001e853273	Product name	2	20171122
b651f154-0364-4007-9dc6-9d33036db1d7	Product name	4	20170808
3395ac9b-f30b-4991-80ba-fd5196be0214	Product name	3	20170802
2d386545-84d1-e1e9-1402-7fc8962353e8	Product name	2	20170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19	Product name	6	20170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8	Product name	4	20170608
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
120cc5ad-761c-444c-9e82-dec22f96dfe1	Product name	7	20161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0c	Product name	1	20160714
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
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508
d0cc7d42-77a7-b452-c6c3-a162fa11225f	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0555-9012-58	Nortrel 7/7/7(28 Day Regimen)	6 in 1 CARTON	KIT	6	18
0555-9012-79	Nortrel 7/7/7(28 Day Regimen)	1 in 1 POUCH	KIT	1	18
0555-9012-79	Nortrel 7/7/7(28 Day Regimen)	1 in 1 BLISTER PACK	KIT	1	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0555-9012-58	EA - Each	0555-9012	b3761772-03ca-4458-af6e-f7c087850f0a	1	2012-07-24
0555-9012-79	EA - Each	0555-9012	5066a15c-a2b9-4ab1-9c2a-163230abe9a8	1	2017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETHINYL ESTRADIOL	ACTIVE INGREDIENT	423D2T571U	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]	7
NORETHINDRONE	ACTIVE INGREDIENT	T18F433X4S	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]	7
ETHINYL ESTRADIOL	ACTIVE MOIETY	423D2T571U	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]	7
NORETHINDRONE	ACTIVE MOIETY	T18F433X4S	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]	7
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]	7
ETHINYL ESTRADIOL	ACTIVE INGREDIENT	423D2T571U	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	1
NORETHINDRONE	ACTIVE INGREDIENT	T18F433X4S	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	1
ETHINYL ESTRADIOL	ACTIVE MOIETY	423D2T571U	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	1
NORETHINDRONE	ACTIVE MOIETY	T18F433X4S	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0555-9012	NORTREL 7/7/7 (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]	17	Current NDC, Legacy NDC, 3 package rows	20220921_992dcc56-90ab-4691-8114-16d47a8b9982.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nortrel 7/7/7 (28 Day Regimen)	NORETHINDRONE AND ETHINYL ESTRADIOL	Proficient Rx LP	5b684f8f-9610-4449-a213-f70bb4a04b8b	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075478 application number: ANDA075478
Nortrel 7/7/7 (28 Day Regimen)	NORETHINDRONE AND ETHINYL ESTRADIOL	Teva Pharmaceuticals USA, Inc.	992dcc56-90ab-4691-8114-16d47a8b9982	2021-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075478 application number: ANDA075478 ndc (product): 0555-9012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
762007	{7 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Nortrel 7/7/7 28 Day]	BPCK	992dcc56-90ab-4691-8114-16d47a8b9982	18
749852	{7 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack	GPCK	992dcc56-90ab-4691-8114-16d47a8b9982	18
749852	Eth estra-Noreth 0.035-0.5 MG (7) Oral Tablet / Eth estra-Noreth 0.035-0.75 MG (7) Oral Tablet / Eth estra-Noreth 0.035-1 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack	PSN	992dcc56-90ab-4691-8114-16d47a8b9982	18
748797	inert 1 MG Oral Tablet	PSN	992dcc56-90ab-4691-8114-16d47a8b9982	18
310463	norethindrone 0.5 MG / ethinyl estradiol 0.035 MG Oral Tablet	PSN	992dcc56-90ab-4691-8114-16d47a8b9982	18
392662	norethindrone 0.75 MG / ethinyl estradiol 0.035 MG Oral Tablet	PSN	992dcc56-90ab-4691-8114-16d47a8b9982	18
312033	norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral Tablet	PSN	992dcc56-90ab-4691-8114-16d47a8b9982	18
762007	Nortrel 7/7/7 28 Day Pack	PSN	992dcc56-90ab-4691-8114-16d47a8b9982	18
310463	ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet	SCD	992dcc56-90ab-4691-8114-16d47a8b9982	18
392662	ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet	SCD	992dcc56-90ab-4691-8114-16d47a8b9982	18
312033	ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet	SCD	992dcc56-90ab-4691-8114-16d47a8b9982	18
748797	inert ingredients 1 MG Oral Tablet	SCD	992dcc56-90ab-4691-8114-16d47a8b9982	18
310463	ethinyl estradiol 35 MCG / norethindrone 0.5 MG Oral Tablet	SY	992dcc56-90ab-4691-8114-16d47a8b9982	18
392662	ethinyl estradiol 35 MCG / norethindrone 0.75 MG Oral Tablet	SY	992dcc56-90ab-4691-8114-16d47a8b9982	18
312033	ethinyl estradiol 35 MCG / norethindrone 1 MG Oral Tablet	SY	992dcc56-90ab-4691-8114-16d47a8b9982	18
762007	Nortrel 7/7/7 28 Day Pack	SY	992dcc56-90ab-4691-8114-16d47a8b9982	18
762007	{7 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Nortrel 7/7/7 28 Day]	BPCK	5b684f8f-9610-4449-a213-f70bb4a04b8b	1
762007	{7 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Nortrel 7/7/7 28 Day]	BPCK	70441908-2e6c-4fdc-9544-e93a5a7223d4	1
749852	{7 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack	GPCK	5b684f8f-9610-4449-a213-f70bb4a04b8b	1
749852	{7 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack	GPCK	70441908-2e6c-4fdc-9544-e93a5a7223d4	1
749852	Eth estra-Noreth 0.035-0.5 MG (7) Oral Tablet / Eth estra-Noreth 0.035-0.75 MG (7) Oral Tablet / Eth estra-Noreth 0.035-1 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack	PSN	70441908-2e6c-4fdc-9544-e93a5a7223d4	1
749852	Eth estra-Noreth 0.035-0.5 MG (7) Oral Tablet / Eth estra-Noreth 0.035-0.75 MG (7) Oral Tablet / Eth estra-Noreth 0.035-1 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack	PSN	5b684f8f-9610-4449-a213-f70bb4a04b8b	1
748797	inert 1 MG Oral Tablet	PSN	70441908-2e6c-4fdc-9544-e93a5a7223d4	1
748797	inert 1 MG Oral Tablet	PSN	5b684f8f-9610-4449-a213-f70bb4a04b8b	1
310463	norethindrone 0.5 MG / ethinyl estradiol 0.035 MG Oral Tablet	PSN	5b684f8f-9610-4449-a213-f70bb4a04b8b	1
310463	norethindrone 0.5 MG / ethinyl estradiol 0.035 MG Oral Tablet	PSN	70441908-2e6c-4fdc-9544-e93a5a7223d4	1
392662	norethindrone 0.75 MG / ethinyl estradiol 0.035 MG Oral Tablet	PSN	70441908-2e6c-4fdc-9544-e93a5a7223d4	1
392662	norethindrone 0.75 MG / ethinyl estradiol 0.035 MG Oral Tablet	PSN	5b684f8f-9610-4449-a213-f70bb4a04b8b	1
312033	norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral Tablet	PSN	70441908-2e6c-4fdc-9544-e93a5a7223d4	1
312033	norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral Tablet	PSN	5b684f8f-9610-4449-a213-f70bb4a04b8b	1
762007	Nortrel 7/7/7 28 Day Pack	PSN	70441908-2e6c-4fdc-9544-e93a5a7223d4	1
762007	Nortrel 7/7/7 28 Day Pack	PSN	5b684f8f-9610-4449-a213-f70bb4a04b8b	1
310463	ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet	SCD	70441908-2e6c-4fdc-9544-e93a5a7223d4	1
310463	ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet	SCD	5b684f8f-9610-4449-a213-f70bb4a04b8b	1
392662	ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet	SCD	70441908-2e6c-4fdc-9544-e93a5a7223d4	1
392662	ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet	SCD	5b684f8f-9610-4449-a213-f70bb4a04b8b	1
312033	ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet	SCD	70441908-2e6c-4fdc-9544-e93a5a7223d4	1
312033	ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet	SCD	5b684f8f-9610-4449-a213-f70bb4a04b8b	1
748797	inert ingredients 1 MG Oral Tablet	SCD	70441908-2e6c-4fdc-9544-e93a5a7223d4	1
748797	inert ingredients 1 MG Oral Tablet	SCD	5b684f8f-9610-4449-a213-f70bb4a04b8b	1
310463	ethinyl estradiol 35 MCG / norethindrone 0.5 MG Oral Tablet	SY	70441908-2e6c-4fdc-9544-e93a5a7223d4	1
310463	ethinyl estradiol 35 MCG / norethindrone 0.5 MG Oral Tablet	SY	5b684f8f-9610-4449-a213-f70bb4a04b8b	1
392662	ethinyl estradiol 35 MCG / norethindrone 0.75 MG Oral Tablet	SY	70441908-2e6c-4fdc-9544-e93a5a7223d4	1
392662	ethinyl estradiol 35 MCG / norethindrone 0.75 MG Oral Tablet	SY	5b684f8f-9610-4449-a213-f70bb4a04b8b	1
312033	ethinyl estradiol 35 MCG / norethindrone 1 MG Oral Tablet	SY	70441908-2e6c-4fdc-9544-e93a5a7223d4	1
312033	ethinyl estradiol 35 MCG / norethindrone 1 MG Oral Tablet	SY	5b684f8f-9610-4449-a213-f70bb4a04b8b	1
762007	Nortrel 7/7/7 28 Day Pack	SY	70441908-2e6c-4fdc-9544-e93a5a7223d4	1
762007	Nortrel 7/7/7 28 Day Pack	SY	5b684f8f-9610-4449-a213-f70bb4a04b8b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0555-9012-58	00555901258	6 POUCH in 1 CARTON (0555-9012-58) / 1 BLISTER PACK in 1 POUCH (0555-9012-79) / 1 KIT in 1 BLISTER PACK	6 pouch	2003-01-02	0000-00-00	No	No	Current
0555-9012-79	00555901279	1 in 1 POUCH						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nortrel ® 7/7/7 (norethindrone and ethinyl estradiol tablets USP, 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg)	Proficient Rx LP	2022-08-01	HUMAN PRESCRIPTION DRUG LABEL	1
Nortrel ® 7/7/7 (norethindrone and ethinyl estradiol tablets USP, 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg)	Teva Pharmaceuticals USA, Inc.	2021-12-01	HUMAN PRESCRIPTION DRUG LABEL	18
Nortrel™ 7/7/7 (norethindrone and ethinyl estradiol tablets, USP 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg)	Physicians Total Care, Inc.	2012-06-01	HUMAN PRESCRIPTION DRUG LABEL	1