Phentermine Hydrochloride

Product NDC
45865-556
11-digit product format
458650556
Labeler code
45865
Product ID
45865-556_7d633912-6179-b99b-e053-2a91aa0af59a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA203068
Marketing category
ANDA
Marketing start
2017-03-21
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
38 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
2020-12-31
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
45865-556-30Phentermine Hydrochloride30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-556PHENTERMINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20181220_7d633912-6178-b99b-e053-2a91aa0af59a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN7d633912-6178-b99b-e053-2a91aa0af59a1
803353phentermine hydrochloride 37.5 MG Oral TabletSCD7d633912-6178-b99b-e053-2a91aa0af59a1
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY7d633912-6178-b99b-e053-2a91aa0af59a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-556-304586505563030 TABLET in 1 BOTTLE (45865-556-30) 30 tablet2018-06-010000-00-00NoNoCurrent