Home NDC 0555-9008 Nortrel
Product NDC 0555-9008
11-digit product format 005559008
Labeler code 0555
Product ID 0555-9008_9ac007e4-792d-4122-8daf-456dea28f82f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone and Ethinyl Estradiol
Dosage form KIT
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA072695
Marketing category ANDA
Marketing start 2001-06-06
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 1 .
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 A072695-001 NORTREL 0.5/35-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET / ORAL-28 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 A072695-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072695-001 NORTREL 0.5/35-28 0.035MG;0.5MG TABLET / ORAL-28 AB 1992-02-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
Additional Listing Data#
Finished product Yes
Brand name base Nortrel
Brand name suffix 28 Day
Listing expiration 2027-12-31 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 0555-9008-67 Nortrel28 Day 3 in 1 CARTON KIT 3 16 0555-9008-79 Nortrel28 Day 1 in 1 POUCH KIT 1 16 0555-9008-79 Nortrel28 Day 1 in 1 BLISTER PACK KIT 1 16
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0555-9008 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
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 0555-9008-67 00555900867 3 POUCH in 1 CARTON (0555-9008-67) / 1 BLISTER PACK in 1 POUCH (0555-9008-79) / 1 KIT in 1 BLISTER PACK 3 pouch 2001-06-06 0000-00-00 No No Current 0555-9008-79 00555900879 1 in 1 POUCH Historical