Nortrel

Product NDC
50090-3229
Requested package NDC
50090-3229-0
11-digit product format
500903229
Labeler code
50090
Product ID
50090-3229_504c5166-e2ca-4a75-bb6a-02798584ca64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone and Ethinyl Estradiol
Dosage form
KIT
Labeler
A-S Medication Solutions
Application
ANDA072695
Marketing category
ANDA
Marketing start
2001-06-06
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072695-001NORTREL 0.5/35-28ETHINYL ESTRADIOL; NORETHINDRONE0.035MG;0.5MGTABLET / ORAL-28AB1992-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A072695-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-283f01610625f2…
2019-09-15 20:21 UTC2019-09A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A072695-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072695-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072695-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072695-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072695-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072695-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072695-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072695-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072695-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072695-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072695-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072695-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072695-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072695-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072695-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072695-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072695-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072695-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072695-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072695-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072695-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A072695-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072695-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072695-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072695-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A072695-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A072695-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072695-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072695-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072695-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072695-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072695-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072695-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072695-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A072695-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A072695-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072695-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072695-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072695-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072695-001AB1cb3db0bc1861…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nortrel 28 DayNORETHINDRONE AND ETHINYL ESTRADIOLA-S Medication Solutions33b895e4-b467-41b1-a812-8068cc5bb93e2024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072695
application number: ANDA072695
ndc (package): 50090-3229-0
ndc (product): 50090-3229
ndc11 (package): 50090322900
Nortrel 28 DayNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.140c50d6-c931-423a-9aa0-526eae7ab93c2021-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072695
application number: ANDA072695

Additional Listing Data#

Finished product
Yes
Brand name base
Nortrel
Brand name suffix
28 Day
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310463Internal RxNorm lookup
748797Internal RxNorm lookup
749879Internal RxNorm lookup
751868Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
33b895e4-b467-41b1-a812-8068cc5bb93eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11Product name420250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
d9a998ac-31a9-4391-9054-c30e50912603Product name220240829
782f1593-b73e-4d35-8017-647969d714d8Product name420240805
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
1a545a57-aed5-4b6e-b1f9-a93c26d50effProduct name120230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689Product name520230627
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9Product name820200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6Product name820191120
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
6dd982ab-2966-22ee-3b75-d225abb791aaProduct name520190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
c21bcd2e-ecbd-48e6-ab68-12cc12256c0fProduct name220190213
60ff9adc-7870-42ca-8836-514bd9732fa8Product name420181220
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
e042bc86-5d40-8945-82f8-de9dd95420ddProduct name620180606
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
390e6d23-3a11-4327-9294-c958a378baaeProduct name420180124
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
b651f154-0364-4007-9dc6-9d33036db1d7Product name420170808
3395ac9b-f30b-4991-80ba-fd5196be0214Product name320170802
2d386545-84d1-e1e9-1402-7fc8962353e8Product name220170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19Product name620170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8Product name420170608
00606b81-6e33-4c38-9ca9-bd14bd74d84cProduct name420170501
f4ce24e8-8632-4fad-9984-b693f985f80fProduct name320170501
b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
f6ac5560-6d3b-d281-41d2-adc50d283c20Product name320170228
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3229-0Nortrel28 Day1 in 1 KITKIT111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3229-0EA - Each50090-3229f54d9b4e-ed79-4b3e-9842-8001eb02c18412021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3229NORTREL 28 DAY (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 1 package rows20240511_33b895e4-b467-41b1-a812-8068cc5bb93e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751868{21 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Nortrel 0.5/35 28 Day]BPCK33b895e4-b467-41b1-a812-8068cc5bb93e11
749879{21 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK33b895e4-b467-41b1-a812-8068cc5bb93e11
749879Eth estra-Noreth 0.035-0.5 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN33b895e4-b467-41b1-a812-8068cc5bb93e11
748797inert 1 MG Oral TabletPSN33b895e4-b467-41b1-a812-8068cc5bb93e11
310463norethindrone 0.5 MG / ethinyl estradiol 0.035 MG Oral TabletPSN33b895e4-b467-41b1-a812-8068cc5bb93e11
751868Nortrel 0.5/35 28 Day PackPSN33b895e4-b467-41b1-a812-8068cc5bb93e11
310463ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral TabletSCD33b895e4-b467-41b1-a812-8068cc5bb93e11
748797inert ingredients 1 MG Oral TabletSCD33b895e4-b467-41b1-a812-8068cc5bb93e11
310463ethinyl estradiol 35 MCG / norethindrone 0.5 MG Oral TabletSY33b895e4-b467-41b1-a812-8068cc5bb93e11
751868Nortrel 0.5/35 28 Day PackSY33b895e4-b467-41b1-a812-8068cc5bb93e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3229-0500903229001 KIT in 1 KIT (50090-3229-0) 1 kit2017-10-300000-00-00NoNoCurrent