Phentermine Hydrochloride

Product NDC
21695-513
11-digit product format
216950513
Labeler code
21695
Product ID
21695-513_29fce92f-babc-45f6-bc50-f3eb5ce7d9fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA040527
Marketing category
ANDA
Marketing start
2003-10-23
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
E
Listing certified through
2017-12-31
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
21695-513-00Phentermine Hydrochloride100 in 1 BOTTLETABLET1001
21695-513-07Phentermine Hydrochloride07 in 1 BOTTLETABLET071
21695-513-30Phentermine Hydrochloride30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-513PHENTERMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 3 package rows20100202_7fb51344-baa4-4905-8ee7-a2db973786fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN7fb51344-baa4-4905-8ee7-a2db973786fc1
803353phentermine hydrochloride 37.5 MG Oral TabletSCD7fb51344-baa4-4905-8ee7-a2db973786fc1
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY7fb51344-baa4-4905-8ee7-a2db973786fc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-513-0021695051300100 in 1 BOTTLEHistorical
21695-513-072169505130707 in 1 BOTTLEHistorical
21695-513-302169505133030 in 1 BOTTLEHistorical