Home NDC 43386-360 Phenelzine Sulfate
Product NDC 43386-360
11-digit product format 433860360
Labeler code 43386
Product ID 43386-360_1eb0b695-ce65-45c2-914a-87bc2105b139
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenelzine Sulfate
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA200181
Marketing category ANDA
Marketing start 2010-12-14
Substance PHENELZINE SULFATE
Active strength 15 mg/1
Pharmacologic classes Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]
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 A200181-001 PHENELZINE SULFATE PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200181-001 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 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200181-001 PHENELZINE SULFATE EQ 15MG BASE TABLET / ORAL AB 2010-12-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Phenelzine Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENELZINE SULFATE 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2681D7P965 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312347 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 43386-360-21 Phenelzine Sulfate 60 in 1 BOTTLE TABLET 60 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENELZINE SULFATE ACTIVE INGREDIENT 2681D7P965 PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 PHENELZINE ACTIVE MOIETY O408N561GF PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-360 PHENELZINE SULFATE TABLET [LUPIN PHARMACEUTICALS,INC.] 3 Current NDC, Legacy NDC, 1 package rows 20171016_40483372-448f-4284-976c-8462ef256661.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 Marketing end Sample Exclude flag Status 43386-360-21 43386036021 60 TABLET in 1 BOTTLE (43386-360-21) 60 tablet 2011-02-14 0000-00-00 No No Current