FDA.reportPublic FDA data

Phentermine

Product NDC
13107-105
11-digit product format
131070105
Labeler code
13107
Product ID
13107-105_53dd7857-41fb-4da1-88f7-5c68a509bfb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurolife Pharma, LLC
Application
ANDA204318
Marketing category
ANDA
Marketing start
2017-03-20
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
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
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
13107-105-01Phentermine100 in 1 BOTTLECAPSULE1004
13107-105-30Phentermine30 in 1 BOTTLECAPSULE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-105PHENTERMINE (PHENTERMINE HYDROCHLORIDE) CAPSULE [AUROLIFE PHARMA, LLC]4Current NDC, Legacy NDC, 2 package rows20190108_737eef3b-9a6b-4ab3-a25c-49d84d2a0197.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN8229adf5-b128-41a5-a3cc-16db4001801c16
900038phentermine HCl 30 MG Oral CapsulePSN8229adf5-b128-41a5-a3cc-16db4001801c16
968766phentermine hydrochloride 15 MG Oral CapsuleSCD8229adf5-b128-41a5-a3cc-16db4001801c16
900038phentermine hydrochloride 30 MG Oral CapsuleSCD8229adf5-b128-41a5-a3cc-16db4001801c16
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY8229adf5-b128-41a5-a3cc-16db4001801c16
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY8229adf5-b128-41a5-a3cc-16db4001801c16
968766phentermine HCl 15 MG Oral CapsulePSN737eef3b-9a6b-4ab3-a25c-49d84d2a01974
900038phentermine HCl 30 MG Oral CapsulePSN737eef3b-9a6b-4ab3-a25c-49d84d2a01974
968766phentermine hydrochloride 15 MG Oral CapsuleSCD737eef3b-9a6b-4ab3-a25c-49d84d2a01974
900038phentermine hydrochloride 30 MG Oral CapsuleSCD737eef3b-9a6b-4ab3-a25c-49d84d2a01974
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY737eef3b-9a6b-4ab3-a25c-49d84d2a01974
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY737eef3b-9a6b-4ab3-a25c-49d84d2a01974

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-105-0113107010501100 CAPSULE in 1 BOTTLE (13107-105-01) 100 capsule2017-03-200000-00-00NoNoCurrent
13107-105-301310701053030 CAPSULE in 1 BOTTLE (13107-105-30) 30 capsule2017-03-200000-00-00NoNoCurrent