FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
0527-1310
11-digit product format
005271310
Labeler code
0527
Product ID
0527-1310_13517af4-9eee-422d-ae02-2a0f09101d74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA087022
Marketing category
ANDA
Marketing start
2007-12-01
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
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
0527-1310-012024-01-30C16284748780-11030e364-fd13-111a-e063-dadaa90a10e24af88a94-22c3-4da1-b8d9-a73ef68a51b6
0527-1310-102024-01-30C16284748780-11030e364-fd13-111a-e063-dadaa90a10e24af88a94-22c3-4da1-b8d9-a73ef68a51b6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1310-01EA - Each0527-1310b96c06ba-d9e6-4224-a81c-102a0ed2e7cf12012-07-24
0527-1310-10EA - Each0527-1310f23963ee-99de-41f0-9ded-48b543f57cef12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
AlcoholINACTIVE INGREDIENT3K9958V90MPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
Anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C Yellow NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C Blue NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
FD&C Blue NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C Red NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C Red NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
GelatinINACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
Methyl AlcoholINACTIVE INGREDIENTY4S76JWI15PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
shellacINACTIVE INGREDIENT46N107B71OPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
900038phentermine HCl 30 MG Oral CapsulePSNa56c3aa5-ca6f-4c14-ab07-fbb3f8be060c4
900038phentermine hydrochloride 30 MG Oral CapsuleSCDa56c3aa5-ca6f-4c14-ab07-fbb3f8be060c4
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYa56c3aa5-ca6f-4c14-ab07-fbb3f8be060c4
900038phentermine HCl 30 MG Oral CapsulePSN9128e039-24e8-45a7-bf22-0309419f86ec2
900038phentermine hydrochloride 30 MG Oral CapsuleSCD9128e039-24e8-45a7-bf22-0309419f86ec2
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY9128e039-24e8-45a7-bf22-0309419f86ec2
900038phentermine HCl 30 MG Oral CapsulePSN7f871c5e-02e5-40f3-a60d-c9d2e9f5ce661
900038phentermine HCl 30 MG Oral CapsulePSN29bd88e3-215d-4c34-b22a-df159a2dd98d1
900038phentermine HCl 30 MG Oral CapsulePSNc8b12e5c-00c9-46e9-943b-c2908113f5bd1
900038phentermine hydrochloride 30 MG Oral CapsuleSCDc8b12e5c-00c9-46e9-943b-c2908113f5bd1
900038phentermine hydrochloride 30 MG Oral CapsuleSCD29bd88e3-215d-4c34-b22a-df159a2dd98d1
900038phentermine hydrochloride 30 MG Oral CapsuleSCD7f871c5e-02e5-40f3-a60d-c9d2e9f5ce661
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY7f871c5e-02e5-40f3-a60d-c9d2e9f5ce661
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY29bd88e3-215d-4c34-b22a-df159a2dd98d1
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYc8b12e5c-00c9-46e9-943b-c2908113f5bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1310-0100527131001100 CAPSULE in 1 BOTTLE (0527-1310-01) 100 capsule2007-12-010000-00-00NoNoCurrent
0527-1310-10005271310101000 CAPSULE in 1 BOTTLE (0527-1310-10) 1000 capsule2007-12-010000-00-00NoNoCurrent