Phentermine Hydrochloride

Product NDC
55289-791
11-digit product format
552890791
Labeler code
55289
Product ID
55289-791_419b6194-7ef1-acbc-e063-6394a90a2315
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
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55289-791-07552890791077 CAPSULE in 1 BOTTLE, PLASTIC (55289-791-07) 7 capsule2012-08-31NoNoHistorical
55289-791-145528907911414 CAPSULE in 1 BOTTLE, PLASTIC (55289-791-14) 14 capsule2012-08-31NoNoHistorical
55289-791-155528907911515 CAPSULE in 1 BOTTLE, PLASTIC (55289-791-15) 15 capsule2012-08-31NoNoHistorical
55289-791-215528907912121 CAPSULE in 1 BOTTLE, PLASTIC (55289-791-21) 21 capsule2012-08-31NoNoHistorical
55289-791-285528907912828 CAPSULE in 1 BOTTLE, PLASTIC (55289-791-28) 28 capsule2012-08-31NoNoHistorical
55289-791-305528907913030 CAPSULE in 1 BOTTLE, PLASTIC (55289-791-30) 30 capsule2012-08-31NoNoHistorical
55289-791-605528907916060 CAPSULE in 1 BOTTLE, PLASTIC (55289-791-60) 60 capsule2012-08-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Phentermine HydrochloridePD-Rx Pharmaceuticals, Inc.2025-10-20HUMAN PRESCRIPTION DRUG LABEL15
Phentermine HydrochloridePD-Rx Pharmaceuticals, Inc.2024-10-04HUMAN PRESCRIPTION DRUG LABEL14