Home NDC 59651-136 Emzahh
Product NDC 59651-136
11-digit product format 596510136
Labeler code 59651
Product ID 59651-136_b785dba5-f0b0-4f74-8845-e845432932c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NORETHINDRONE
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA216796
Marketing category ANDA
Marketing start 2023-01-06
Substance NORETHINDRONE
Active strength .35 mg/1
Pharmacologic classes 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 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 A216796-001 EMZAHH NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2023-01-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216796-001 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.
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 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216796-001 EMZAHH 0.35MG TABLET / ORAL-28 AB2 2023-01-06 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Emzahh
Listing expiration 2026-12-31 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 2626828 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-136 EMZAHH (NORETHINDRONE) TABLET [AUROBINDO PHARMA LIMITED] 2 Current NDC, 6 package rows 20230422_197d31d3-eec8-49c7-9640-918ff138fea2.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-136-28 59651013628 1 BLISTER PACK in 1 CARTON (59651-136-28) / 1 TABLET in 1 BLISTER PACK 1 blister pack 2023-01-06 No No Current 59651-136-88 59651013688 3 POUCH in 1 CARTON (59651-136-88) / 1 TABLET in 1 POUCH 3 pouch 2023-01-06 No No Current 59651-136-92 59651013692 6 POUCH in 1 CARTON (59651-136-92) / 1 TABLET in 1 POUCH 6 pouch 2023-01-06 No No Current