Home NDC 60505-3438 Selegiline Hydrochloride
Product NDC 60505-3438
11-digit product format 605053438
Labeler code 60505
Product ID 60505-3438_1f213cd2-ca80-aa07-6f27-a5093d23da13
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Selegiline Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Apotex Corp.
Application ANDA074871
Marketing category ANDA
Marketing start 1997-07-06
Substance SELEGILINE HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B 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 A074871-001 SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074871-001 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 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074871-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1997-06-06 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 Selegiline Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SELEGILINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6W731X367Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 859193 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 60505-3438-3 Selegiline Hydrochloride 60 in 1 BOTTLE TABLET 60 7 60505-3438-8 Selegiline Hydrochloride 500 in 1 BOTTLE TABLET 500 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SELEGILINE HYDROCHLORIDE ACTIVE INGREDIENT 6W731X367Q SELEGILINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 SELEGILINE HYDROCHLORIDE ACTIVE INGREDIENT 6W731X367Q SELEGILINE HYDROCHLORIDE TABLET [APOTEX CORP.] 2 SELEGILINE ACTIVE MOIETY 2K1V7GP655 SELEGILINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 SELEGILINE ACTIVE MOIETY 2K1V7GP655 SELEGILINE HYDROCHLORIDE TABLET [APOTEX CORP.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK SELEGILINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK SELEGILINE HYDROCHLORIDE TABLET [APOTEX CORP.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SELEGILINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SELEGILINE HYDROCHLORIDE TABLET [APOTEX CORP.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SELEGILINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SELEGILINE HYDROCHLORIDE TABLET [APOTEX CORP.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SELEGILINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SELEGILINE HYDROCHLORIDE TABLET [APOTEX CORP.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-3438 SELEGILINE HYDROCHLORIDE TABLET [APOTEX CORP.] 6 Current NDC, Legacy NDC, 2 package rows 20241003_2aa9f8ee-6a86-6cf1-bec7-6a1ffa5e1ae2.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 · 3 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 60505-3438-3 60505343803 60 TABLET in 1 BOTTLE (60505-3438-3) 60 tablet 1997-07-06 0000-00-00 No No Current 60505-3438-8 60505343808 500 TABLET in 1 BOTTLE (60505-3438-8) 500 tablet 1997-07-06 0000-00-00 No No Current