FDA.reportPublic FDA data

Phentermine hydrochloride

Product NDC
11534-160
11-digit product format
115340160
Labeler code
11534
Product ID
11534-160_a9fd0c08-60ae-4015-85c7-803989d00745
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phentermine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
SUNRISE PHARMACEUTICAL, INC.
Application
ANDA205008
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
11534-160-01Phentermine hydrochloride100 in 1 BOTTLETABLET1007
11534-160-03Phentermine hydrochloride1000 in 1 BOTTLETABLET10007
11534-160-30Phentermine hydrochloride30 in 1 BOTTLETABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11534-160-01EA - Each11534-1601d2b0652-19a1-40bd-aaa3-ffa5542cdfd212017-03-06
11534-160-03EA - Each11534-16017e0ff88-ee32-48f3-be1d-04fd40d62fc812017-03-06
11534-160-30EA - Each11534-1608494bb49-deef-45fe-851e-e07ccd18f60512017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11534-160PHENTERMINE 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
803353phentermine HCl 37.5 MG Oral TabletPSN99c1325b-7152-481d-8a1f-6bf3e2c4808b105
803353phentermine hydrochloride 37.5 MG Oral TabletSCD99c1325b-7152-481d-8a1f-6bf3e2c4808b105
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY99c1325b-7152-481d-8a1f-6bf3e2c4808b105
803353phentermine HCl 37.5 MG Oral TabletPSN50efa498-11c5-41fa-95ac-419fcc10da03104
803353phentermine hydrochloride 37.5 MG Oral TabletSCD50efa498-11c5-41fa-95ac-419fcc10da03104
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY50efa498-11c5-41fa-95ac-419fcc10da03104
803353phentermine HCl 37.5 MG Oral TabletPSNe0a6a289-7dbf-4b24-b815-46dee0d19fdc103
803353phentermine hydrochloride 37.5 MG Oral TabletSCDe0a6a289-7dbf-4b24-b815-46dee0d19fdc103
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYe0a6a289-7dbf-4b24-b815-46dee0d19fdc103
803353phentermine HCl 37.5 MG Oral TabletPSNe08b4f49-de9f-490d-b11d-d865439f5fad101
803353phentermine hydrochloride 37.5 MG Oral TabletSCDe08b4f49-de9f-490d-b11d-d865439f5fad101
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYe08b4f49-de9f-490d-b11d-d865439f5fad101
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
803353phentermine HCl 37.5 MG Oral TabletPSN129e781c-5366-4986-8e67-6b35fa4c3f395
803353phentermine hydrochloride 37.5 MG Oral TabletSCD129e781c-5366-4986-8e67-6b35fa4c3f395
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY129e781c-5366-4986-8e67-6b35fa4c3f395
803353phentermine HCl 37.5 MG Oral TabletPSN3d1d4dde-1c7f-4a20-b8f8-897b1b284f803
803353phentermine hydrochloride 37.5 MG Oral TabletSCD3d1d4dde-1c7f-4a20-b8f8-897b1b284f803
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY3d1d4dde-1c7f-4a20-b8f8-897b1b284f803
803353phentermine HCl 37.5 MG Oral TabletPSN1fa8798d-c096-5839-e063-6394a90aa28b2
803353phentermine HCl 37.5 MG Oral TabletPSN28fda2ce-d445-47ce-8764-bf113b5db5b32
803353phentermine hydrochloride 37.5 MG Oral TabletSCD1fa8798d-c096-5839-e063-6394a90aa28b2
803353phentermine hydrochloride 37.5 MG Oral TabletSCD28fda2ce-d445-47ce-8764-bf113b5db5b32
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY28fda2ce-d445-47ce-8764-bf113b5db5b32
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY1fa8798d-c096-5839-e063-6394a90aa28b2
803353phentermine HCl 37.5 MG Oral TabletPSN9155edf8-ea1d-458f-b2a7-e0303fd83cc01
803353phentermine HCl 37.5 MG Oral TabletPSNde76ed27-ac43-4923-b73f-461d33941f6b1
803353phentermine HCl 37.5 MG Oral TabletPSN12ee1dc8-d82b-e174-e063-6294a90ac1bc1
803353phentermine hydrochloride 37.5 MG Oral TabletSCD9155edf8-ea1d-458f-b2a7-e0303fd83cc01
803353phentermine hydrochloride 37.5 MG Oral TabletSCDde76ed27-ac43-4923-b73f-461d33941f6b1
803353phentermine hydrochloride 37.5 MG Oral TabletSCD12ee1dc8-d82b-e174-e063-6294a90ac1bc1
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY9155edf8-ea1d-458f-b2a7-e0303fd83cc01
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYde76ed27-ac43-4923-b73f-461d33941f6b1
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY12ee1dc8-d82b-e174-e063-6294a90ac1bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11534-160-0111534016001100 TABLET in 1 BOTTLE (11534-160-01) 100 tablet2017-01-240000-00-00NoNoCurrent
11534-160-03115340160031000 TABLET in 1 BOTTLE (11534-160-03) 1000 tablet2017-01-240000-00-00NoNoCurrent
11534-160-301153401603030 TABLET in 1 BOTTLE (11534-160-30) 30 tablet2017-01-240000-00-00NoNoCurrent