FDA.reportPublic FDA data

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

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
Rxcui968766

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
55289-791-07Phentermine Hydrochloride7 in 1 BOTTLE, PLASTICCAPSULE715
55289-791-14Phentermine Hydrochloride14 in 1 BOTTLE, PLASTICCAPSULE1415
55289-791-15Phentermine Hydrochloride15 in 1 BOTTLE, PLASTICCAPSULE1515
55289-791-21Phentermine Hydrochloride21 in 1 BOTTLE, PLASTICCAPSULE2115
55289-791-28Phentermine Hydrochloride28 in 1 BOTTLE, PLASTICCAPSULE2815
55289-791-30Phentermine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE3015
55289-791-60Phentermine Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE6015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-791-07EA - Each55289-791fcc53bcd-3e33-4e42-995c-2a6f0925fe6c12013-02-13
55289-791-14EA - Each55289-79115724f66-03fc-49dc-9f14-5b974445dc5712013-02-13
55289-791-15EA - Each55289-79109b79c00-145b-4c80-bf92-51dc9fd1ea6212013-02-13
55289-791-21EA - Each55289-79170c24af3-88fa-4578-9376-e165615f51c912013-02-13
55289-791-28EA - Each55289-7915153c435-3658-44a4-ae55-0c1a7eeae16b12013-02-13
55289-791-30EA - Each55289-79163d85601-e6a1-4737-9bbe-deaae5c5994f12013-02-13
55289-791-60EA - Each55289-7917f0bf4aa-bbd4-4df2-83d1-7cb2f8a706ba12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-791PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 7 package rows20241006_4000c00f-aa6c-4ea5-af0e-149dde3c74db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN4000c00f-aa6c-4ea5-af0e-149dde3c74db15
968766phentermine hydrochloride 15 MG Oral CapsuleSCD4000c00f-aa6c-4ea5-af0e-149dde3c74db15
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY4000c00f-aa6c-4ea5-af0e-149dde3c74db15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-791-07552890791077 CAPSULE in 1 BOTTLE, PLASTIC (55289-791-07) 7 capsule2012-08-310000-00-00NoNoCurrent
55289-791-145528907911414 CAPSULE in 1 BOTTLE, PLASTIC (55289-791-14) 14 capsule2012-08-310000-00-00NoNoCurrent
55289-791-155528907911515 CAPSULE in 1 BOTTLE, PLASTIC (55289-791-15) 15 capsule2012-08-310000-00-00NoNoCurrent
55289-791-215528907912121 CAPSULE in 1 BOTTLE, PLASTIC (55289-791-21) 21 capsule2012-08-310000-00-00NoNoCurrent
55289-791-285528907912828 CAPSULE in 1 BOTTLE, PLASTIC (55289-791-28) 28 capsule2012-08-310000-00-00NoNoCurrent
55289-791-305528907913030 CAPSULE in 1 BOTTLE, PLASTIC (55289-791-30) 30 capsule2012-08-310000-00-00NoNoCurrent
55289-791-605528907916060 CAPSULE in 1 BOTTLE, PLASTIC (55289-791-60) 60 capsule2012-08-310000-00-00NoNoCurrent