Phentermine Hydrochloride

Product NDC
50090-2536
11-digit product format
500902536
Labeler code
50090
Product ID
50090-2536_a1c0c926-2674-48d9-901d-cecac877c4aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202248
Marketing category
ANDA
Marketing start
2012-02-17
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
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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui900038

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
50090-2536-02023-02-07C16284748780-19d75b9d0-7ed9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP C IV Initial U.S. Approval: 1959
50090-2536-32023-02-07C16284748780-19d75b9d0-7ed9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP C IV Initial U.S. Approval: 1959
50090-2536-42023-02-07C16284748780-19d75b9d0-7ed9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP C IV Initial U.S. Approval: 1959
50090-2536-02023-01-30C16284748780-19d75b9d0-7ed9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP C IV Initial U.S. Approval: 1959
50090-2536-32023-01-30C16284748780-19d75b9d0-7ed9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP C IV Initial U.S. Approval: 1959
50090-2536-42023-01-30C16284748780-19d75b9d0-7ed9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP C IV Initial U.S. Approval: 1959
50090-2536-02020-02-17C16284748780-19d75b9d0-7ed9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP C IV Initial U.S. Approval: 1959
50090-2536-42020-02-17C16284748780-19d75b9d0-7ed9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP C IV Initial U.S. Approval: 1959
50090-2536-02020-01-31C16284748780-19d75b9d0-7ed9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP C IV Initial U.S. Approval: 1959
50090-2536-42020-01-31C16284748780-19d75b9d0-7ed9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP C IV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2536-0Phentermine Hydrochloride30 in 1 BOTTLECAPSULE3016
50090-2536-3Phentermine Hydrochloride7 in 1 BOTTLECAPSULE716
50090-2536-4Phentermine Hydrochloride28 in 1 BOTTLECAPSULE2816

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2536PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 3 package rows20230208_8c7c1391-bfd1-48f9-b249-9729fe648b89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN8c7c1391-bfd1-48f9-b249-9729fe648b8916
900038phentermine hydrochloride 30 MG Oral CapsuleSCD8c7c1391-bfd1-48f9-b249-9729fe648b8916
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY8c7c1391-bfd1-48f9-b249-9729fe648b8916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2536-05009025360030 CAPSULE in 1 BOTTLE (50090-2536-0) 30 capsule2016-10-190000-00-00NoNoCurrent
50090-2536-3500902536037 CAPSULE in 1 BOTTLE (50090-2536-3) 7 capsule2017-10-120000-00-00NoNoCurrent
50090-2536-45009025360428 CAPSULE in 1 BOTTLE (50090-2536-4) 28 capsule2016-12-190000-00-00NoNoCurrent