FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
11534-157
11-digit product format
115340157
Labeler code
11534
Product ID
11534-157_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
15 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 HYDROCHLORIDE15 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
11534-157-01Phentermine Hydrochloride100 in 1 BOTTLECAPSULE1007
11534-157-03Phentermine Hydrochloride1000 in 1 BOTTLECAPSULE10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11534-157-01EA - Each11534-157ac441594-a5d5-426e-97a4-500032982a6f12017-03-06
11534-157-03EA - Each11534-157d7ccac07-9c21-4106-96fd-73322cb2785812017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11534-157PHENTERMINE 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
968766phentermine HCl 15 MG Oral CapsulePSN3c37d637-779d-4097-85ef-e4ce7d0fb86a105
968766phentermine hydrochloride 15 MG Oral CapsuleSCD3c37d637-779d-4097-85ef-e4ce7d0fb86a105
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY3c37d637-779d-4097-85ef-e4ce7d0fb86a105
968766phentermine HCl 15 MG Oral CapsulePSNf50f5453-e06d-4e39-b868-9bdadf1d8baa104
968766phentermine hydrochloride 15 MG Oral CapsuleSCDf50f5453-e06d-4e39-b868-9bdadf1d8baa104
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSYf50f5453-e06d-4e39-b868-9bdadf1d8baa104
968766phentermine HCl 15 MG Oral CapsulePSN640d71d8-45c9-42fb-ad96-2f3ac60afc9c103
968766phentermine hydrochloride 15 MG Oral CapsuleSCD640d71d8-45c9-42fb-ad96-2f3ac60afc9c103
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY640d71d8-45c9-42fb-ad96-2f3ac60afc9c103
968766phentermine HCl 15 MG Oral CapsulePSNa1bca4b5-df64-4bac-a3a2-67f5c1eddbce101
968766phentermine hydrochloride 15 MG Oral CapsuleSCDa1bca4b5-df64-4bac-a3a2-67f5c1eddbce101
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSYa1bca4b5-df64-4bac-a3a2-67f5c1eddbce101
968766phentermine HCl 15 MG Oral CapsulePSNc53bd3c5-01f6-4a21-9e3c-aa4969a01b4b8
968766phentermine hydrochloride 15 MG Oral CapsuleSCDc53bd3c5-01f6-4a21-9e3c-aa4969a01b4b8
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSYc53bd3c5-01f6-4a21-9e3c-aa4969a01b4b8
968766phentermine HCl 15 MG Oral CapsulePSN70bc6f36-8087-4ccd-a396-a911c0ebae797
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
968766phentermine hydrochloride 15 MG Oral CapsuleSCD70bc6f36-8087-4ccd-a396-a911c0ebae797
900038phentermine hydrochloride 30 MG Oral CapsuleSCDa0439c85-5ede-4e02-aed2-47debd2c8eb27
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY70bc6f36-8087-4ccd-a396-a911c0ebae797
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
968766phentermine HCl 15 MG Oral CapsulePSNd7984a71-d70a-3e88-e053-2a95a90a97a24
968766phentermine hydrochloride 15 MG Oral CapsuleSCDd7984a71-d70a-3e88-e053-2a95a90a97a24
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSYd7984a71-d70a-3e88-e053-2a95a90a97a24
968766phentermine HCl 15 MG Oral CapsulePSNd24aaa53-9c78-4c1b-9495-c785a9cf2b263
968766phentermine hydrochloride 15 MG Oral CapsuleSCDd24aaa53-9c78-4c1b-9495-c785a9cf2b263
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSYd24aaa53-9c78-4c1b-9495-c785a9cf2b263
968766phentermine HCl 15 MG Oral CapsulePSN5c1f88ba-d7d6-4b48-b951-c5e65d87e8742
968766phentermine HCl 15 MG Oral CapsulePSNe4a2996e-2bfa-376f-e053-2995a90a0ed12
968766phentermine hydrochloride 15 MG Oral CapsuleSCD5c1f88ba-d7d6-4b48-b951-c5e65d87e8742
968766phentermine hydrochloride 15 MG Oral CapsuleSCDe4a2996e-2bfa-376f-e053-2995a90a0ed12
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY5c1f88ba-d7d6-4b48-b951-c5e65d87e8742
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSYe4a2996e-2bfa-376f-e053-2995a90a0ed12
968766phentermine HCl 15 MG Oral CapsulePSN22683183-a828-47a4-9e52-38175d7c6f211
900038phentermine HCl 30 MG Oral CapsulePSN22683183-a828-47a4-9e52-38175d7c6f211
968766phentermine hydrochloride 15 MG Oral CapsuleSCD22683183-a828-47a4-9e52-38175d7c6f211
900038phentermine hydrochloride 30 MG Oral CapsuleSCD22683183-a828-47a4-9e52-38175d7c6f211
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11534-157-0111534015701100 CAPSULE in 1 BOTTLE (11534-157-01) 100 capsule2017-01-240000-00-00NoNoCurrent
11534-157-03115340157031000 CAPSULE in 1 BOTTLE (11534-157-03) 1000 capsule2017-01-240000-00-00NoNoCurrent