Phentermine hydrochloride

Product NDC
11534-159
11-digit product format
115340159
Labeler code
11534
Product ID
11534-159_a9fd0c08-60ae-4015-85c7-803989d00745
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phentermine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
SUNRISE PHARMACEUTICAL, INC.
Application
ANDA205017
Marketing category
ANDA
Marketing start
2017-01-24
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
37.5 mg/1
Pharmacologic classes
Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIV
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
A205017-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAARS2014-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205017-001AA

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 UTC2026-02A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAARS2014-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAARS2014-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAARS2014-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAARS2014-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAARS2014-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAARS2014-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAARS2014-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAARS2014-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAARS2014-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAARS2014-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAARS2014-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAARS2014-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAARS2014-09-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAARS2014-09-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-253f01610625f2…
2019-09-15 20:21 UTC2019-09A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAARS2014-09-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205017-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2014-09-25cb3db0bc1861…

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 UTC2026-02A205017-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205017-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205017-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205017-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205017-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205017-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205017-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205017-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205017-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205017-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205017-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205017-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205017-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205017-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205017-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205017-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205017-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205017-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205017-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205017-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205017-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A205017-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205017-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205017-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205017-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A205017-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205017-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205017-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205017-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205017-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205017-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205017-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205017-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205017-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205017-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205017-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205017-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205017-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205017-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205017-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE37.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0K2I505OTVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
803348Internal RxNorm lookup
803353Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
43024f64-2d77-49a9-80fd-ad07a86c69a3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
32c2b0bd-1f13-4890-99e0-dcd2ea16e1abProduct name220230717
ebeae3eb-385d-62da-8827-5ffa80b14e90Product name220170810
1d682039-1122-1cb7-f3f4-c0a028b98748Product name420170124
8ef9ca65-1a6c-7225-351d-36066d0f8e56Product name320161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11534-159-01Phentermine hydrochloride100 in 1 BOTTLECAPSULE1007
11534-159-03Phentermine hydrochloride1000 in 1 BOTTLECAPSULE10007
11534-159-30Phentermine hydrochloride30 in 1 BOTTLECAPSULE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11534-159-01EA - Each11534-1593dab908a-6889-4ea0-b9fc-b3690fd7da7712017-03-06
11534-159-03EA - Each11534-1598775a336-e740-46f2-820d-e1f293b2b09012017-03-06
11534-159-30EA - Each11534-159a728ab13-3c18-4ff5-91dd-47664108927012017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11534-159PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [SUNRISE PHARMACEUTICAL, INC.]7Current NDC, Legacy NDC, 3 package rows20241206_43024f64-2d77-49a9-80fd-ad07a86c69a3.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack4686bc8d-7173-477e-96c8-a7d33653df2e2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205017
application number: ANDA205017
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack70f68311-8d1f-4b8e-b8a7-13bc4c17727e2025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205017
application number: ANDA205017
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack86a6ce50-673d-4031-87a0-51965cc1e7952025-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205017
application number: ANDA205017
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack6b08ccd5-d01f-48f1-80a2-1d121f445d422025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205017
application number: ANDA205017
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack5d84078d-ff2d-4800-b2f4-f1d30c8335bb2025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205017
application number: ANDA205017
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDESUNRISE PHARMACEUTICAL, INC.43024f64-2d77-49a9-80fd-ad07a86c69a32024-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205017
application number: ANDA205017
ndc (product): 11534-159

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803348phentermine HCl 37.5 MG Oral CapsulePSN4686bc8d-7173-477e-96c8-a7d33653df2e105
803348phentermine hydrochloride 37.5 MG Oral CapsuleSCD4686bc8d-7173-477e-96c8-a7d33653df2e105
803348phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral CapsuleSY4686bc8d-7173-477e-96c8-a7d33653df2e105
803348phentermine HCl 37.5 MG Oral CapsulePSN6b08ccd5-d01f-48f1-80a2-1d121f445d42104
803348phentermine hydrochloride 37.5 MG Oral CapsuleSCD6b08ccd5-d01f-48f1-80a2-1d121f445d42104
803348phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral CapsuleSY6b08ccd5-d01f-48f1-80a2-1d121f445d42104
803348phentermine HCl 37.5 MG Oral CapsulePSN5d84078d-ff2d-4800-b2f4-f1d30c8335bb103
803348phentermine hydrochloride 37.5 MG Oral CapsuleSCD5d84078d-ff2d-4800-b2f4-f1d30c8335bb103
803348phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral CapsuleSY5d84078d-ff2d-4800-b2f4-f1d30c8335bb103
803348phentermine HCl 37.5 MG Oral CapsulePSN70f68311-8d1f-4b8e-b8a7-13bc4c17727e101
803348phentermine hydrochloride 37.5 MG Oral CapsuleSCD70f68311-8d1f-4b8e-b8a7-13bc4c17727e101
803348phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral CapsuleSY70f68311-8d1f-4b8e-b8a7-13bc4c17727e101
803348phentermine HCl 37.5 MG Oral CapsulePSN86a6ce50-673d-4031-87a0-51965cc1e7959
803348phentermine hydrochloride 37.5 MG Oral CapsuleSCD86a6ce50-673d-4031-87a0-51965cc1e7959
803348phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral CapsuleSY86a6ce50-673d-4031-87a0-51965cc1e7959
803348phentermine HCl 37.5 MG Oral CapsulePSN43024f64-2d77-49a9-80fd-ad07a86c69a37
803353phentermine HCl 37.5 MG Oral TabletPSN43024f64-2d77-49a9-80fd-ad07a86c69a37
803348phentermine hydrochloride 37.5 MG Oral CapsuleSCD43024f64-2d77-49a9-80fd-ad07a86c69a37
803353phentermine hydrochloride 37.5 MG Oral TabletSCD43024f64-2d77-49a9-80fd-ad07a86c69a37
803348phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral CapsuleSY43024f64-2d77-49a9-80fd-ad07a86c69a37
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY43024f64-2d77-49a9-80fd-ad07a86c69a37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11534-159-0111534015901100 CAPSULE in 1 BOTTLE (11534-159-01) 100 capsule2017-01-240000-00-00NoNoCurrent
11534-159-03115340159031000 CAPSULE in 1 BOTTLE (11534-159-03) 1000 capsule2017-01-240000-00-00NoNoCurrent
11534-159-301153401593030 CAPSULE in 1 BOTTLE (11534-159-30) 30 capsule2017-01-240000-00-00NoNoCurrent