Home NDC 70700-314-79 LUIZZA 1.5/30
Product NDC 70700-314
Requested package NDC 70700-314-79
11-digit product format 707000314
Labeler code 70700
Product ID 70700-314_689d38d7-80e3-b31c-396d-313bccdf7b33
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name norethindrone acetate and ethinyl estradiol
Dosage form TABLET
Route ORAL
Labeler Xiromed LLC
Application ANDA202770
Marketing category ANDA
Marketing start 2025-01-29
Substance ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Active strength 30; 1.5 ug/1; mg/1
Pharmacologic classes 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 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 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202770-001 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 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 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 LUIZZA 1.5/30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETHINYL ESTRADIOL 30 ug/1 NORETHINDRONE ACETATE 1.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 423D2T571U Internal UNII lookup 9S44LIC7OJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1359022 Internal RxNorm lookup 1359028 Internal RxNorm lookup 2712092 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 70700-314-78 LUIZZA 1.5/30 1 in 1 POUCH TABLET 1 1 70700-314-78 LUIZZA 1.5/30 21 in 1 BLISTER PACK TABLET 21 1 70700-314-79 LUIZZA 1.5/30 3 in 1 CARTON TABLET 3 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70700-314 LUIZZA 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [XIROMED LLC] 1 Current NDC, 3 package rows 20250418_b1c3e33d-ec95-cd89-7ad9-36994c802a1f.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70700-314-79 70700031479 3 POUCH in 1 CARTON (70700-314-79) / 1 BLISTER PACK in 1 POUCH (70700-314-78) / 21 TABLET in 1 BLISTER PACK 3 pouch 2025-01-29 No No Current