FDA.reportPublic FDA data

PHENTERMINE HYDROCHLORIDE

Product NDC
61919-186
11-digit product format
619190186
Labeler code
61919
Product ID
61919-186_b1a71882-78f9-297e-e053-2a95a90a760e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTERMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA040555
Marketing category
ANDA
Marketing start
2020-10-14
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
2021-12-31
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
61919-186-072025-01-30C16284748780-12cef2736-6c6e-d83d-e063-dadaa90ab31fPHENTERMINE HCL C-IV
61919-186-142025-01-30C16284748780-12cef2736-6c6e-d83d-e063-dadaa90ab31fPHENTERMINE HCL C-IV
61919-186-302024-01-30C16284748780-11030e365-44b1-111a-e063-dadaa90a10e2PHENTERMINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-186-30PHENTERMINE HYDROCHLORIDE30 in 1 BOTTLETABLET308
61919-186-07PHENTERMINE HYDROCHLORIDE7 in 1 BOTTLETABLET76
61919-186-14PHENTERMINE HYDROCHLORIDE14 in 1 BOTTLETABLET146

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-186-30EA - Each61919-186fb97e723-3c78-4aaf-b8ad-d1410a8bc0a412014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-186PHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]8Legacy NDC, 1 package rows20200122_501437ae-f4a2-4e54-b033-eccc53a06037.zip
61919-186PHENTERMINE HCL C-IV CAPSULE PHENTERMINE HYDROCHLORIDE TABLET [DIRECT_RX]6Legacy NDC, 2 package rows20230413_8a947cf6-c578-0405-e053-2995a90a3e0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN501437ae-f4a2-4e54-b033-eccc53a060378
803353phentermine hydrochloride 37.5 MG Oral TabletSCD501437ae-f4a2-4e54-b033-eccc53a060378
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY501437ae-f4a2-4e54-b033-eccc53a060378
900038phentermine HCl 30 MG Oral CapsulePSN8a947cf6-c578-0405-e053-2995a90a3e0e6
803353phentermine HCl 37.5 MG Oral TabletPSN8a947cf6-c578-0405-e053-2995a90a3e0e6
900038phentermine hydrochloride 30 MG Oral CapsuleSCD8a947cf6-c578-0405-e053-2995a90a3e0e6
803353phentermine hydrochloride 37.5 MG Oral TabletSCD8a947cf6-c578-0405-e053-2995a90a3e0e6
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY8a947cf6-c578-0405-e053-2995a90a3e0e6
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY8a947cf6-c578-0405-e053-2995a90a3e0e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-186-07619190186077 TABLET in 1 BOTTLE (61919-186-07) 7 tablet2020-10-140000-00-00NoNoCurrent
61919-186-146191901861414 TABLET in 1 BOTTLE (61919-186-14) 14 tablet2020-10-140000-00-00NoNoCurrent
61919-186-306191901863030 TABLET in 1 BOTTLE (61919-186-30) 30 tablet2014-01-010000-00-00NoNoCurrent