FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
50090-1696
11-digit product format
500901696
Labeler code
50090
Product ID
50090-1696_6c819f0e-d3be-4b8c-9fc0-4cb8f7e52f06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040525
Marketing category
ANDA
Marketing start
2003-10-23
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
30 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1696-02020-01-31C16284748780-19d75b9d1-1ed5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE CAPSULES. PHENTERMINE HYDROCHLORIDE capsules, for oral use, CIV Initial U.S. Approval: 1959
50090-1696-32020-01-31C16284748780-19d75b9d1-1ed5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE CAPSULES. PHENTERMINE HYDROCHLORIDE capsules, for oral use, CIV Initial U.S. Approval: 1959
50090-1696-42020-01-31C16284748780-19d75b9d1-1ed5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE CAPSULES. PHENTERMINE HYDROCHLORIDE capsules, for oral use, CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1696-0Phentermine Hydrochloride30 in 1 BOTTLECAPSULE303
50090-1696-3Phentermine Hydrochloride7 in 1 BOTTLECAPSULE73
50090-1696-4Phentermine Hydrochloride28 in 1 BOTTLECAPSULE283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1696PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 3 package rows20180108_d5bbd0ea-cd63-46fe-8b6a-b3448e990da7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSNd5bbd0ea-cd63-46fe-8b6a-b3448e990da73
900038phentermine hydrochloride 30 MG Oral CapsuleSCDd5bbd0ea-cd63-46fe-8b6a-b3448e990da73
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYd5bbd0ea-cd63-46fe-8b6a-b3448e990da73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-1696-05009016960030 in 1 BOTTLEHistorical
50090-1696-3500901696037 in 1 BOTTLEHistorical
50090-1696-45009016960428 in 1 BOTTLEHistorical