FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
11534-176
11-digit product format
115340176
Labeler code
11534
Product ID
11534-176_9d9ffca5-9d09-4d92-a8af-18f9f6b24989
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phentermine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
SUNRISE PHARMACEUTICAL, INC.
Application
ANDA205019
Marketing category
ANDA
Marketing start
2017-01-24
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
30 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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui900038, 968766

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
11534-176-01Phentermine Hydrochloride100 in 1 BOTTLECAPSULE1007
11534-176-03Phentermine Hydrochloride1000 in 1 BOTTLECAPSULE10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11534-176-01EA - Each11534-17639c47926-69cd-4c89-a52b-76d5049d8af612017-03-06
11534-176-03EA - Each11534-176a40f5713-7176-4e92-8d0c-9566b9a5f4b612017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11534-176PHENTERMINE HYDROCHLORIDE CAPSULE [SUNRISE PHARMACEUTICAL, INC.]6Current NDC, Legacy NDC, 2 package rows20220929_a0439c85-5ede-4e02-aed2-47debd2c8eb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSNf427f067-f1a7-4d60-8ce0-90b20e2d4eb5105
900038phentermine HCl 30 MG Oral CapsulePSNc8516abe-5ad1-4b76-8e2c-96ee455979cf105
900038phentermine hydrochloride 30 MG Oral CapsuleSCDf427f067-f1a7-4d60-8ce0-90b20e2d4eb5105
900038phentermine hydrochloride 30 MG Oral CapsuleSCDc8516abe-5ad1-4b76-8e2c-96ee455979cf105
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYf427f067-f1a7-4d60-8ce0-90b20e2d4eb5105
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYc8516abe-5ad1-4b76-8e2c-96ee455979cf105
900038phentermine HCl 30 MG Oral CapsulePSNfe78b5b4-47bf-484b-ab37-e0d7de6fad57103
900038phentermine HCl 30 MG Oral CapsulePSN81751ece-8ccb-4aec-91ad-037c1d9fea53103
900038phentermine hydrochloride 30 MG Oral CapsuleSCDfe78b5b4-47bf-484b-ab37-e0d7de6fad57103
900038phentermine hydrochloride 30 MG Oral CapsuleSCD81751ece-8ccb-4aec-91ad-037c1d9fea53103
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY81751ece-8ccb-4aec-91ad-037c1d9fea53103
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYfe78b5b4-47bf-484b-ab37-e0d7de6fad57103
900038phentermine HCl 30 MG Oral CapsulePSNa9270c14-499f-4c07-a1eb-c0aab5d8731f101
900038phentermine hydrochloride 30 MG Oral CapsuleSCDa9270c14-499f-4c07-a1eb-c0aab5d8731f101
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYa9270c14-499f-4c07-a1eb-c0aab5d8731f101
900038phentermine HCl 30 MG Oral CapsulePSNe4508aa9-1e7a-4af7-829e-5fa353c92f5e11
900038phentermine hydrochloride 30 MG Oral CapsuleSCDe4508aa9-1e7a-4af7-829e-5fa353c92f5e11
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYe4508aa9-1e7a-4af7-829e-5fa353c92f5e11
968766phentermine HCl 15 MG Oral CapsulePSNa0439c85-5ede-4e02-aed2-47debd2c8eb27
900038phentermine HCl 30 MG Oral CapsulePSNa0439c85-5ede-4e02-aed2-47debd2c8eb27
968766phentermine hydrochloride 15 MG Oral CapsuleSCDa0439c85-5ede-4e02-aed2-47debd2c8eb27
900038phentermine hydrochloride 30 MG Oral CapsuleSCDa0439c85-5ede-4e02-aed2-47debd2c8eb27
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSYa0439c85-5ede-4e02-aed2-47debd2c8eb27
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYa0439c85-5ede-4e02-aed2-47debd2c8eb27
900038phentermine HCl 30 MG Oral CapsulePSNd77f31b4-7e36-4a0a-a55b-78b4b6ab5cb76
900038phentermine hydrochloride 30 MG Oral CapsuleSCDd77f31b4-7e36-4a0a-a55b-78b4b6ab5cb76
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYd77f31b4-7e36-4a0a-a55b-78b4b6ab5cb76
900038phentermine HCl 30 MG Oral CapsulePSNee00aeb4-7cae-77d1-e053-2a95a90ab2183
900038phentermine hydrochloride 30 MG Oral CapsuleSCDee00aeb4-7cae-77d1-e053-2a95a90ab2183
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYee00aeb4-7cae-77d1-e053-2a95a90ab2183
900038phentermine HCl 30 MG Oral CapsulePSNca683656-16a6-9602-e053-2a95a90aa8952
900038phentermine hydrochloride 30 MG Oral CapsuleSCDca683656-16a6-9602-e053-2a95a90aa8952
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYca683656-16a6-9602-e053-2a95a90aa8952
968766phentermine HCl 15 MG Oral CapsulePSN22683183-a828-47a4-9e52-38175d7c6f211
900038phentermine HCl 30 MG Oral CapsulePSNfa5de92d-a5bf-4ae1-8e13-ad827aeebea31
900038phentermine HCl 30 MG Oral CapsulePSN22683183-a828-47a4-9e52-38175d7c6f211
900038phentermine HCl 30 MG Oral CapsulePSN5e1cc734-5d5c-429e-8b4c-4401a01cfba21
968766phentermine hydrochloride 15 MG Oral CapsuleSCD22683183-a828-47a4-9e52-38175d7c6f211
900038phentermine hydrochloride 30 MG Oral CapsuleSCD22683183-a828-47a4-9e52-38175d7c6f211
900038phentermine hydrochloride 30 MG Oral CapsuleSCDfa5de92d-a5bf-4ae1-8e13-ad827aeebea31
900038phentermine hydrochloride 30 MG Oral CapsuleSCD5e1cc734-5d5c-429e-8b4c-4401a01cfba21
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY22683183-a828-47a4-9e52-38175d7c6f211
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY22683183-a828-47a4-9e52-38175d7c6f211
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYfa5de92d-a5bf-4ae1-8e13-ad827aeebea31
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY5e1cc734-5d5c-429e-8b4c-4401a01cfba21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11534-176-0111534017601100 CAPSULE in 1 BOTTLE (11534-176-01) 100 capsule2017-01-240000-00-00NoNoCurrent
11534-176-03115340176031000 CAPSULE in 1 BOTTLE (11534-176-03) 1000 capsule2017-01-240000-00-00NoNoCurrent