Phentermine Hydrochloride

Product NDC
53217-334
11-digit product format
532170334
Labeler code
53217
Product ID
53217-334_389f4d7b-285d-4b25-bdc0-dd3b10db9d8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA087022
Marketing category
ANDA
Marketing start
2012-01-20
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-334-30Phentermine Hydrochloride30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-334PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180601_35d26955-2ad7-4f84-9b51-6a573933a396.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN35d26955-2ad7-4f84-9b51-6a573933a3961
968766phentermine hydrochloride 15 MG Oral CapsuleSCD35d26955-2ad7-4f84-9b51-6a573933a3961
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY35d26955-2ad7-4f84-9b51-6a573933a3961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-334-305321703343030 in 1 BOTTLEHistorical