Home NDC 70700-317 MELEYA
Product NDC 70700-317
11-digit product format 707000317
Labeler code 70700
Product ID 70700-317_69e5efc0-ad4e-4c21-e2c7-36d3f77207e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone
Dosage form TABLET
Route ORAL
Labeler Xiromed LLC
Application ANDA200980
Marketing category ANDA
Marketing start 2025-01-29
Substance NORETHINDRONE
Active strength .35 mg/1
Pharmacologic classes 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 44 .
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 A200980-001 NORETHINDRONE NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200980-001 AB2
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 · 44 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 2026-10-15 13:18:30 2026-09 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 c2088c7a36db…2026-09-14 22:38:34 2026-08 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 MELEYA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NORETHINDRONE .35 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T18F433X4S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198042 Internal RxNorm lookup 748961 Internal RxNorm lookup 2716571 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 70700-317-84 MELEYA 1 in 1 POUCH TABLET 1 2 70700-317-84 MELEYA 28 in 1 BLISTER PACK TABLET 28 2 70700-317-85 MELEYA 3 in 1 CARTON TABLET 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70700-317 MELEYA (NORETHINDRONE) TABLET [XIROMED LLC] 2 Current NDC, 3 package rows 20250418_534c5717-382c-4109-3208-e21b32e4c4c9.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70700-317-84 70700031784 1 in 1 POUCH Historical 70700-317-85 70700031785 3 POUCH in 1 CARTON (70700-317-85) / 1 BLISTER PACK in 1 POUCH (70700-317-84) / 28 TABLET in 1 BLISTER PACK 3 pouch 2025-01-29 No No Current