Home NDC 72319-006 Selegiline Hydrochloride
Product NDC 72319-006
11-digit product format 723190006
Labeler code 72319
Product ID 72319-006_248576e6-bc11-e847-e063-6294a90afe9d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Selegiline Hydrochloride
Dosage form TABLET
Route ORAL
Labeler i3 Pharmaceuticals, LLC
Application ANDA074672
Marketing category ANDA
Marketing start 2021-12-15
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 A074672-001 SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074672-001 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 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1997-04-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1997-04-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1997-04-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1997-04-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1997-04-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1997-04-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1997-04-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1997-04-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1997-04-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074672-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL AB 1997-04-01 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 72319-006-02 Selegiline Hydrochloride 60 in 1 BOTTLE TABLET 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72319-006 SELEGILINE HYDROCHLORIDE TABLET [I3 PHARMACEUTICALS, LLC] 5 Current NDC, Legacy NDC, 1 package rows 20241116_c81e983b-455d-2e65-e053-2a95a90a3123.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 Marketing end Sample Exclude flag Status 72319-006-02 72319000602 60 TABLET in 1 BOTTLE (72319-006-02) 60 tablet 2021-12-15 0000-00-00 No No Current