Home NDC 0555-9009 Nortrel
Product NDC 0555-9009
11-digit product format 005559009
Labeler code 0555
Product ID 0555-9009_9ac007e4-792d-4122-8daf-456dea28f82f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone and Ethinyl Estradiol
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA072693
Marketing category ANDA
Marketing start 2001-06-13
Substance NORETHINDRONE; ETHINYL ESTRADIOL
Active strength 1; .035 mg/1; mg/1
Pharmacologic classes Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072693-001 NORTREL 1/35-21 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072693-001 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 2 · 43 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 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072693-001 NORTREL 1/35-21 0.035MG;1MG TABLET / ORAL-21 AB 1992-02-28 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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
Brand name suffix 21 Day
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NORETHINDRONE 1 mg/1 ETHINYL ESTRADIOL .035 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T18F433X4S Internal UNII lookup 423D2T571U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 9 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310463 Internal RxNorm lookup 312033 Internal RxNorm lookup 748797 Internal RxNorm lookup 749858 Internal RxNorm lookup 749869 Internal RxNorm lookup 749879 Internal RxNorm lookup 751868 Internal RxNorm lookup 751870 Internal RxNorm lookup 751871 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0555-9009-42 Nortrel21 Day 3 in 1 CARTON TABLET 3 16 0555-9009-80 Nortrel21 Day 1 in 1 POUCH TABLET 1 16 0555-9009-80 Nortrel21 Day 21 in 1 BLISTER PACK TABLET 21 16
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0555-9009 NORTREL 21 DAY (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL 28 DAY (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.] 15 Current NDC, Legacy NDC, 3 package rows 20250316_140c50d6-c931-423a-9aa0-526eae7ab93c.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nortrel 28 Day NORETHINDRONE AND ETHINYL ESTRADIOL Teva Pharmaceuticals USA, Inc. 140c50d6-c931-423a-9aa0-526eae7ab93c 2021-12-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072693 application number: ANDA072693 ndc (product): 0555-9009
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0555-9009-42 00555900942 3 POUCH in 1 CARTON (0555-9009-42) / 1 BLISTER PACK in 1 POUCH (0555-9009-80) / 21 TABLET in 1 BLISTER PACK 3 pouch 2001-06-13 0000-00-00 No No Current 0555-9009-80 00555900980 1 in 1 POUCH Historical