Phentermine Hydrochloride

Product NDC
84053-026
11-digit product format
840530026
Labeler code
84053
Product ID
84053-026_3a9e49c7-cd54-cb92-e063-6394a90a1978
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Martek Pharmacal Co.
Application
ANDA040886
Marketing category
ANDA
Marketing start
2024-05-31
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
84053-026-21Phentermine Hydrochloride21 in 1 BOTTLECAPSULE212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84053-026PHENTERMINE HYDROCHLORIDE CAPSULE [MARTEK PHARMACAL CO.]1Current NDC, 1 package rows20240531_1fe86035-19ef-4944-ad81-c0167a8e7fec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN1fe86035-19ef-4944-ad81-c0167a8e7fec2
968766phentermine hydrochloride 15 MG Oral CapsuleSCD1fe86035-19ef-4944-ad81-c0167a8e7fec2
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY1fe86035-19ef-4944-ad81-c0167a8e7fec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84053-026-218405300262121 CAPSULE in 1 BOTTLE (84053-026-21) 21 capsule2024-05-31NoNoCurrent