FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
0527-1743
11-digit product format
005271743
Labeler code
0527
Product ID
0527-1743_fa4eafdd-0a89-46fd-aedf-7ccd5776c42a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA201961
Marketing category
ANDA
Marketing start
2011-07-20
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
2023-12-31
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
0527-1743-012024-01-30C16284748780-11030e365-059c-111a-e063-dadaa90a10e2b7fd9015-83f3-431a-90e2-4fe68006754e
0527-1743-102024-01-30C16284748780-11030e365-059c-111a-e063-dadaa90a10e2b7fd9015-83f3-431a-90e2-4fe68006754e
0527-1743-302024-01-30C16284748780-11030e365-059c-111a-e063-dadaa90a10e2b7fd9015-83f3-431a-90e2-4fe68006754e

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1743-01EA - Each0527-17437910379c-bb7e-488e-82c7-6f180ec31d7d12012-07-24
0527-1743-10EA - Each0527-174365abee08-2050-455e-a7ed-8543e29fecd712012-07-24
0527-1743-30EA - Each0527-1743319a63f3-a133-462f-b2d7-cb1ac77d222112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OPHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803348phentermine HCl 37.5 MG Oral CapsulePSN6ee6b57c-bb5f-4062-8626-bf8e102ad3208
803348phentermine hydrochloride 37.5 MG Oral CapsuleSCD6ee6b57c-bb5f-4062-8626-bf8e102ad3208
803348phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral CapsuleSY6ee6b57c-bb5f-4062-8626-bf8e102ad3208
803348phentermine HCl 37.5 MG Oral CapsulePSNefa6398d-fd9c-48f4-a91f-5a91b4ae5b5e2
803348phentermine hydrochloride 37.5 MG Oral CapsuleSCDefa6398d-fd9c-48f4-a91f-5a91b4ae5b5e2
803348phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral CapsuleSYefa6398d-fd9c-48f4-a91f-5a91b4ae5b5e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1743-0100527174301100 CAPSULE in 1 BOTTLE (0527-1743-01) 100 capsule2011-07-200000-00-00NoNoCurrent
0527-1743-10005271743101000 CAPSULE in 1 BOTTLE (0527-1743-10) 1000 capsule2011-07-200000-00-00NoNoCurrent
0527-1743-300052717433030 CAPSULE in 1 BOTTLE (0527-1743-30) 30 capsule2011-07-200000-00-00NoNoCurrent