FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
55289-624
11-digit product format
552890624
Labeler code
55289
Product ID
55289-624_419b1893-64bb-45c2-e063-6294a90acac8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040875
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
55289-624-07Phentermine Hydrochloride7 in 1 BOTTLE, PLASTICCAPSULE721
55289-624-14Phentermine Hydrochloride14 in 1 BOTTLE, PLASTICCAPSULE1421
55289-624-28Phentermine Hydrochloride28 in 1 BOTTLE, PLASTICCAPSULE2821
55289-624-30Phentermine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE3021
55289-624-60Phentermine Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE6021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-624-07EA - Each55289-6247b8d91df-3a41-4343-8809-9a390ed9885a12013-02-13
55289-624-14EA - Each55289-624e8ffe597-e8b2-4053-beb9-58004babebad12013-02-13
55289-624-28EA - Each55289-6249f8ce7d2-91f4-41fd-80d2-de3ce4e5761a12013-02-13
55289-624-30EA - Each55289-62422468225-1d16-4b0f-a7d5-2cfc3970799312013-02-13
55289-624-60EA - Each55289-62421f123d5-d776-40bc-8631-c960e03605ca12013-02-13

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 RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-624PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 5 package rows20241006_6749c074-52a1-4d74-96a2-d9302b3c49a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN6749c074-52a1-4d74-96a2-d9302b3c49a121
900038phentermine hydrochloride 30 MG Oral CapsuleSCD6749c074-52a1-4d74-96a2-d9302b3c49a121
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY6749c074-52a1-4d74-96a2-d9302b3c49a121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-624-07552890624077 CAPSULE in 1 BOTTLE, PLASTIC (55289-624-07) 7 capsule2012-08-310000-00-00NoNoCurrent
55289-624-145528906241414 CAPSULE in 1 BOTTLE, PLASTIC (55289-624-14) 14 capsule2012-08-310000-00-00NoNoCurrent
55289-624-285528906242828 CAPSULE in 1 BOTTLE, PLASTIC (55289-624-28) 28 capsule2012-08-310000-00-00NoNoCurrent
55289-624-305528906243030 CAPSULE in 1 BOTTLE, PLASTIC (55289-624-30) 30 capsule2012-08-310000-00-00NoNoCurrent
55289-624-605528906246060 CAPSULE in 1 BOTTLE, PLASTIC (55289-624-60) 60 capsule2012-08-310000-00-00NoNoCurrent