Selegiline Hydrochloride

Product NDC
71335-2673
11-digit product format
713352673
Labeler code
71335
Product ID
71335-2673_f2fc35e0-f99a-4a92-85d4-1e2d1f9fbac2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selegiline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206803
Marketing category
ANDA
Marketing start
2019-04-02
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206803-001SELEGILINE HYDROCHLORIDESELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A206803-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-023f01610625f2…
2019-09-15 20:21 UTC2019-09A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206803-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB2019-04-02cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206803-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206803-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206803-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206803-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206803-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206803-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206803-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206803-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206803-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206803-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206803-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206803-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206803-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206803-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206803-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206803-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206803-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206803-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206803-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206803-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206803-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A206803-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206803-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206803-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206803-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A206803-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206803-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206803-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206803-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206803-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206803-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206803-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206803-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206803-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206803-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206803-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206803-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206803-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206803-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206803-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Selegiline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELEGILINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6W731X367QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
859186Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4848270a-1179-410c-b4e6-a7e555b3a988Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6780a268-60d0-4c35-b9cf-cd4360ac8329Product name120190702
897f5455-61fe-1903-6c67-bd52e2f7ffbeProduct name120140508
98710086-9ad6-ee93-d125-b72fb2fc859aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2673-1Selegiline Hydrochloride30 in 1 BOTTLECAPSULE301

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEBryant Ranch Prepack4848270a-1179-410c-b4e6-a7e555b3a9882025-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206803
application number: ANDA206803
ndc (product): 71335-2673
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDERising Pharma Holdings, Inc.23c4481f-d150-40c6-addb-b3e454ca914f2024-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206803
application number: ANDA206803
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEProficient Rx LP57b564ef-c89b-4cf6-a11f-f67391d74e7e2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206803
application number: ANDA206803

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859186selegiline HCl 5 MG Oral CapsulePSN4848270a-1179-410c-b4e6-a7e555b3a9881
859186selegiline hydrochloride 5 MG Oral CapsuleSCD4848270a-1179-410c-b4e6-a7e555b3a9881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2673-17133526730130 CAPSULE in 1 BOTTLE (71335-2673-1) 30 capsule2025-07-15NoNoCurrent