FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
50090-1679
11-digit product format
500901679
Labeler code
50090
Product ID
50090-1679_a471924e-e01a-4665-9ba1-1eaea935a7ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040876
Marketing category
ANDA
Marketing start
2012-08-15
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
37.5 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui803353

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
50090-1679-02023-02-07C16284748780-1f386c64a-32d2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-12023-02-07C16284748780-1f386c64a-32d2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-22023-02-07C16284748780-1f386c64a-32d2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-32023-02-07C16284748780-1f386c64a-32d2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-42023-02-07C16284748780-1f386c64a-32d2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-52023-02-07C16284748780-1f386c64a-32d2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-62023-02-07C16284748780-1f386c64a-32d2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-02023-01-30C16284748780-1f386c64a-32d2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-12023-01-30C16284748780-1f386c64a-32d2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-22023-01-30C16284748780-1f386c64a-32d2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-32023-01-30C16284748780-1f386c64a-32d2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-42023-01-30C16284748780-1f386c64a-32d2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-52023-01-30C16284748780-1f386c64a-32d2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-62023-01-30C16284748780-1f386c64a-32d2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1679-0Phentermine Hydrochloride30 in 1 BOTTLETABLET3021
50090-1679-1Phentermine Hydrochloride45 in 1 BOTTLETABLET4521
50090-1679-2Phentermine Hydrochloride60 in 1 BOTTLETABLET6021
50090-1679-3Phentermine Hydrochloride28 in 1 BOTTLETABLET2821
50090-1679-4Phentermine Hydrochloride7 in 1 BOTTLETABLET721
50090-1679-5Phentermine Hydrochloride14 in 1 BOTTLETABLET1421
50090-1679-6Phentermine Hydrochloride90 in 1 BOTTLETABLET9021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1679PHENTERMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]19Current NDC, Legacy NDC, 7 package rows20231227_86ec6b9d-2934-4bad-8a80-0b60e2f912f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN86ec6b9d-2934-4bad-8a80-0b60e2f912f321
803353phentermine hydrochloride 37.5 MG Oral TabletSCD86ec6b9d-2934-4bad-8a80-0b60e2f912f321
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY86ec6b9d-2934-4bad-8a80-0b60e2f912f321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1679-05009016790030 TABLET in 1 BOTTLE (50090-1679-0) 30 tablet2015-02-030000-00-00NoNoCurrent
50090-1679-15009016790145 TABLET in 1 BOTTLE (50090-1679-1) 45 tablet2015-02-030000-00-00NoNoCurrent
50090-1679-25009016790260 TABLET in 1 BOTTLE (50090-1679-2) 60 tablet2015-02-030000-00-00NoNoCurrent
50090-1679-35009016790328 TABLET in 1 BOTTLE (50090-1679-3) 28 tablet2015-04-280000-00-00NoNoCurrent
50090-1679-4500901679047 TABLET in 1 BOTTLE (50090-1679-4) 7 tablet2015-04-280000-00-00NoNoCurrent
50090-1679-55009016790514 TABLET in 1 BOTTLE (50090-1679-5) 14 tablet2015-04-280000-00-00NoNoCurrent
50090-1679-65009016790690 TABLET in 1 BOTTLE (50090-1679-6) 90 tablet2018-08-060000-00-00NoNoCurrent