Phentermine Hydrochloride

Product NDC
43063-961
11-digit product format
430630961
Labeler code
43063
Product ID
43063-961_415f45d4-861d-6191-e063-6394a90a2a0a
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
43063-961-01Phentermine Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-961-01EA - Each43063-961abf3290d-cf19-4cc7-9328-79846582b1ec12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-961PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 1 package rows20241115_f115ad6d-cf62-40e7-89d1-6183a9b5071f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSNf115ad6d-cf62-40e7-89d1-6183a9b5071f15
968766phentermine hydrochloride 15 MG Oral CapsuleSCDf115ad6d-cf62-40e7-89d1-6183a9b5071f15
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSYf115ad6d-cf62-40e7-89d1-6183a9b5071f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-961-0143063096101100 CAPSULE in 1 BOTTLE, PLASTIC (43063-961-01) 100 capsule2019-04-010000-00-00NoNoCurrent