FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
12634-687
11-digit product format
126340687
Labeler code
12634
Product ID
12634-687_36713557-ab03-3c88-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA040526
Marketing category
ANDA
Marketing start
2003-10-23
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
2019-12-31
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
12634-687-002020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-012020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-092020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-402020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-422020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-452020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-502020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-522020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-542020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-572020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-582020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-592020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-602020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-612020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-632020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-662020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-672020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-692020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-712020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-742020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-782020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-792020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-802020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-812020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-822020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-842020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-852020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-902020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-912020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-922020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-932020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-942020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-952020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-962020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-972020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-982020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
12634-687-992020-01-31C16284748780-19d75b9d0-415f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-687-00Phentermine Hydrochloride10 in 1 BOTTLETABLET103
12634-687-01Phentermine Hydrochloride100 in 1 BOTTLETABLET1003
12634-687-09Phentermine Hydrochloride35 in 1 BOTTLETABLET353
12634-687-40Phentermine Hydrochloride40 in 1 BOTTLETABLET403
12634-687-42Phentermine Hydrochloride42 in 1 BOTTLETABLET423
12634-687-45Phentermine Hydrochloride45 in 1 BOTTLETABLET453
12634-687-50Phentermine Hydrochloride50 in 1 BOTTLETABLET503
12634-687-52Phentermine Hydrochloride12 in 1 BLISTER PACKTABLET123
12634-687-54Phentermine Hydrochloride14 in 1 BLISTER PACKTABLET143
12634-687-57Phentermine Hydrochloride20 in 1 BLISTER PACKTABLET203
12634-687-58Phentermine Hydrochloride28 in 1 BLISTER PACKTABLET283
12634-687-59Phentermine Hydrochloride30 in 1 BLISTER PACKTABLET303
12634-687-60Phentermine Hydrochloride60 in 1 BOTTLETABLET603
12634-687-61Phentermine Hydrochloride10 in 1 BLISTER PACKTABLET103
12634-687-63Phentermine Hydrochloride3 in 1 BLISTER PACKTABLET33
12634-687-66Phentermine Hydrochloride6 in 1 BLISTER PACKTABLET63
12634-687-67Phentermine Hydrochloride7 in 1 BLISTER PACKTABLET73
12634-687-69Phentermine Hydrochloride9 in 1 BLISTER PACKTABLET93
12634-687-71Phentermine Hydrochloride30 in 1 BOTTLETABLET303
12634-687-74Phentermine Hydrochloride24 in 1 BOTTLETABLET243
12634-687-78Phentermine Hydrochloride28 in 1 BOTTLETABLET283
12634-687-79Phentermine Hydrochloride25 in 1 BOTTLETABLET253
12634-687-80Phentermine Hydrochloride20 in 1 BOTTLETABLET203
12634-687-81Phentermine Hydrochloride21 in 1 BOTTLETABLET213
12634-687-82Phentermine Hydrochloride12 in 1 BOTTLETABLET123
12634-687-84Phentermine Hydrochloride14 in 1 BOTTLETABLET143
12634-687-85Phentermine Hydrochloride15 in 1 BOTTLETABLET153
12634-687-90Phentermine Hydrochloride90 in 1 BOTTLETABLET903
12634-687-91Phentermine Hydrochloride1 in 1 BLISTER PACKTABLET13
12634-687-92Phentermine Hydrochloride2 in 1 BOTTLETABLET23
12634-687-93Phentermine Hydrochloride3 in 1 BOTTLETABLET33
12634-687-94Phentermine Hydrochloride4 in 1 BOTTLETABLET43
12634-687-95Phentermine Hydrochloride5 in 1 BOTTLETABLET53
12634-687-96Phentermine Hydrochloride6 in 1 BOTTLETABLET63
12634-687-97Phentermine Hydrochloride7 in 1 BOTTLETABLET73
12634-687-98Phentermine Hydrochloride8 in 1 BOTTLETABLET83
12634-687-99Phentermine Hydrochloride9 in 1 BOTTLETABLET93

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-687PHENTERMINE HYDROCHLORIDE TABLET [APOTHECA INC.]3Legacy NDC, 37 package rows20160701_027d77a3-6d62-498b-8901-86f1f73362d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN027d77a3-6d62-498b-8901-86f1f73362d53
803353phentermine hydrochloride 37.5 MG Oral TabletSCD027d77a3-6d62-498b-8901-86f1f73362d53
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY027d77a3-6d62-498b-8901-86f1f73362d53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-687-001263406870010 in 1 BOTTLEHistorical
12634-687-0112634068701100 in 1 BOTTLEHistorical
12634-687-091263406870935 in 1 BOTTLEHistorical
12634-687-401263406874040 in 1 BOTTLEHistorical
12634-687-421263406874242 in 1 BOTTLEHistorical
12634-687-451263406874545 in 1 BOTTLEHistorical
12634-687-501263406875050 in 1 BOTTLEHistorical
12634-687-521263406875212 in 1 BLISTER PACKHistorical
12634-687-541263406875414 in 1 BLISTER PACKHistorical
12634-687-571263406875720 in 1 BLISTER PACKHistorical
12634-687-581263406875828 in 1 BLISTER PACKHistorical
12634-687-591263406875930 in 1 BLISTER PACKHistorical
12634-687-601263406876060 in 1 BOTTLEHistorical
12634-687-611263406876110 in 1 BLISTER PACKHistorical
12634-687-63126340687633 in 1 BLISTER PACKHistorical
12634-687-66126340687666 in 1 BLISTER PACKHistorical
12634-687-67126340687677 in 1 BLISTER PACKHistorical
12634-687-69126340687699 in 1 BLISTER PACKHistorical
12634-687-711263406877130 in 1 BOTTLEHistorical
12634-687-741263406877424 in 1 BOTTLEHistorical
12634-687-781263406877828 in 1 BOTTLEHistorical
12634-687-791263406877925 in 1 BOTTLEHistorical
12634-687-801263406878020 in 1 BOTTLEHistorical
12634-687-811263406878121 in 1 BOTTLEHistorical
12634-687-821263406878212 in 1 BOTTLEHistorical
12634-687-841263406878414 in 1 BOTTLEHistorical
12634-687-851263406878515 in 1 BOTTLEHistorical
12634-687-901263406879090 in 1 BOTTLEHistorical
12634-687-91126340687911 in 1 BLISTER PACKHistorical
12634-687-92126340687922 in 1 BOTTLEHistorical
12634-687-93126340687933 in 1 BOTTLEHistorical
12634-687-94126340687944 in 1 BOTTLEHistorical
12634-687-95126340687955 in 1 BOTTLEHistorical
12634-687-96126340687966 in 1 BOTTLEHistorical
12634-687-97126340687977 in 1 BOTTLEHistorical
12634-687-98126340687988 in 1 BOTTLEHistorical
12634-687-99126340687999 in 1 BOTTLEHistorical