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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0K2I505OTVPHENTERMINE HYDROCHLORIDE1197-21-3PHENTERMINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43063-654-304306306543030 CAPSULE in 1 BOTTLE, PLASTIC (43063-654-30) 30 capsule2016-02-03NoNoHistorical
43063-654-604306306546060 CAPSULE in 1 BOTTLE, PLASTIC (43063-654-60) 60 capsule2016-02-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Phentermine HydrochloridePD-Rx Pharmaceuticals, Inc.2025-10-15HUMAN PRESCRIPTION DRUG LABEL12
Phentermine HydrochloridePD-Rx Pharmaceuticals, Inc.2024-06-04HUMAN PRESCRIPTION DRUG LABEL11