FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui803348, 803353

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

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