FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
43063-654
11-digit product format
430630654
Labeler code
43063
Product ID
43063-654_4139ec53-8914-8199-e063-6394a90a3c2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040886
Marketing category
ANDA
Marketing start
2012-08-07
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

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
43063-654-30Phentermine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE3012
43063-654-60Phentermine Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-654-30EA - Each43063-654d6cdcd2a-56bb-4889-a041-9afb90e49d1512016-03-04
43063-654-60EA - Each43063-65438e40a3f-4e74-41ee-a764-42e3bd73e62f12016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-654PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 2 package rows20240606_2abc445c-daa8-7326-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN2abc445c-daa8-7326-e054-00144ff88e8812
900038phentermine hydrochloride 30 MG Oral CapsuleSCD2abc445c-daa8-7326-e054-00144ff88e8812
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY2abc445c-daa8-7326-e054-00144ff88e8812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-654-304306306543030 CAPSULE in 1 BOTTLE, PLASTIC (43063-654-30) 30 capsule2016-02-030000-00-00NoNoCurrent
43063-654-604306306546060 CAPSULE in 1 BOTTLE, PLASTIC (43063-654-60) 60 capsule2016-02-030000-00-00NoNoCurrent