Phendimetrazine Tartrate

Product NDC
12634-910
11-digit product format
126340910
Labeler code
12634
Product ID
12634-910_366ecdba-3d58-63e5-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Apotheca Inc.
Application
NDA018074
Marketing category
NDA
Marketing start
1977-09-06
Marketing end
0000-00-00
Substance
PHENDIMETRAZINE TARTRATE
Active strength
105 mg/1
Pharmacologic classes
Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIII
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
71525015-bcb9-5864-7749-4b5f528a6b6aProduct name220180419
977c925f-5460-67b1-e843-25a0ba370df1Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12634-910-002020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-012020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-092020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-402020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-422020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-452020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-502020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-522020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-542020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-572020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-582020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-592020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-602020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-612020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-632020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-662020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-672020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-692020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-712020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-742020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-782020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-792020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-802020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-812020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-822020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-842020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-852020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-902020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-912020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-922020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-932020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-942020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-952020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-962020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-972020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-982020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
12634-910-992020-01-31C16284748780-19d75b9d0-4189-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-910-00Phendimetrazine Tartrate10 in 1 BOTTLECAPSULE, EXTENDED RELEASE105
12634-910-01Phendimetrazine Tartrate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1005
12634-910-09Phendimetrazine Tartrate35 in 1 BOTTLECAPSULE, EXTENDED RELEASE355
12634-910-40Phendimetrazine Tartrate40 in 1 BOTTLECAPSULE, EXTENDED RELEASE405
12634-910-42Phendimetrazine Tartrate42 in 1 BOTTLECAPSULE, EXTENDED RELEASE425
12634-910-45Phendimetrazine Tartrate45 in 1 BOTTLECAPSULE, EXTENDED RELEASE455
12634-910-50Phendimetrazine Tartrate50 in 1 BOTTLECAPSULE, EXTENDED RELEASE505
12634-910-52Phendimetrazine Tartrate12 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE125
12634-910-54Phendimetrazine Tartrate14 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE145
12634-910-57Phendimetrazine Tartrate20 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE205
12634-910-58Phendimetrazine Tartrate28 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE285
12634-910-59Phendimetrazine Tartrate30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE305
12634-910-60Phendimetrazine Tartrate60 in 1 BOTTLECAPSULE, EXTENDED RELEASE605
12634-910-61Phendimetrazine Tartrate10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE105
12634-910-63Phendimetrazine Tartrate3 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE35
12634-910-66Phendimetrazine Tartrate6 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE65
12634-910-67Phendimetrazine Tartrate7 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE75
12634-910-69Phendimetrazine Tartrate9 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE95
12634-910-71Phendimetrazine Tartrate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305
12634-910-74Phendimetrazine Tartrate24 in 1 BOTTLECAPSULE, EXTENDED RELEASE245
12634-910-78Phendimetrazine Tartrate28 in 1 BOTTLECAPSULE, EXTENDED RELEASE285
12634-910-79Phendimetrazine Tartrate25 in 1 BOTTLECAPSULE, EXTENDED RELEASE255
12634-910-80Phendimetrazine Tartrate20 in 1 BOTTLECAPSULE, EXTENDED RELEASE205
12634-910-81Phendimetrazine Tartrate21 in 1 BOTTLECAPSULE, EXTENDED RELEASE215
12634-910-82Phendimetrazine Tartrate12 in 1 BOTTLECAPSULE, EXTENDED RELEASE125
12634-910-84Phendimetrazine Tartrate14 in 1 BOTTLECAPSULE, EXTENDED RELEASE145
12634-910-85Phendimetrazine Tartrate15 in 1 BOTTLECAPSULE, EXTENDED RELEASE155
12634-910-90Phendimetrazine Tartrate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE905
12634-910-91Phendimetrazine Tartrate1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE15
12634-910-92Phendimetrazine Tartrate2 in 1 BOTTLECAPSULE, EXTENDED RELEASE25
12634-910-93Phendimetrazine Tartrate3 in 1 BOTTLECAPSULE, EXTENDED RELEASE35
12634-910-94Phendimetrazine Tartrate4 in 1 BOTTLECAPSULE, EXTENDED RELEASE45
12634-910-95Phendimetrazine Tartrate5 in 1 BOTTLECAPSULE, EXTENDED RELEASE55
12634-910-96Phendimetrazine Tartrate6 in 1 BOTTLECAPSULE, EXTENDED RELEASE65
12634-910-97Phendimetrazine Tartrate7 in 1 BOTTLECAPSULE, EXTENDED RELEASE75
12634-910-98Phendimetrazine Tartrate8 in 1 BOTTLECAPSULE, EXTENDED RELEASE85
12634-910-99Phendimetrazine Tartrate9 in 1 BOTTLECAPSULE, EXTENDED RELEASE95

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENDIMETRAZINE TARTRATEACTIVE INGREDIENT6985IP0T80PHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
PHENDIMETRAZINEACTIVE MOIETYAB2794W8KVPHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LPHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554PHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-910PHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [APOTHECA INC.]5Legacy NDC, 37 package rows20160702_5803a3c0-7434-40f3-af5e-cf33b3e2c448.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979543phendimetrazine tartrate 105 MG 24HR Extended Release Oral CapsulePSN5803a3c0-7434-40f3-af5e-cf33b3e2c4485
97954324 HR phendimetrazine tartrate 105 MG Extended Release Oral CapsuleSCD5803a3c0-7434-40f3-af5e-cf33b3e2c4485
979543phendimetrazine 105 MG 24 HR Extended Release Oral CapsuleSY5803a3c0-7434-40f3-af5e-cf33b3e2c4485

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-910-001263409100010 in 1 BOTTLEHistorical
12634-910-0112634091001100 in 1 BOTTLEHistorical
12634-910-091263409100935 in 1 BOTTLEHistorical
12634-910-401263409104040 in 1 BOTTLEHistorical
12634-910-421263409104242 in 1 BOTTLEHistorical
12634-910-451263409104545 in 1 BOTTLEHistorical
12634-910-501263409105050 in 1 BOTTLEHistorical
12634-910-521263409105212 in 1 BLISTER PACKHistorical
12634-910-541263409105414 in 1 BLISTER PACKHistorical
12634-910-571263409105720 in 1 BLISTER PACKHistorical
12634-910-581263409105828 in 1 BLISTER PACKHistorical
12634-910-591263409105930 in 1 BLISTER PACKHistorical
12634-910-601263409106060 in 1 BOTTLEHistorical
12634-910-611263409106110 in 1 BLISTER PACKHistorical
12634-910-63126340910633 in 1 BLISTER PACKHistorical
12634-910-66126340910666 in 1 BLISTER PACKHistorical
12634-910-67126340910677 in 1 BLISTER PACKHistorical
12634-910-69126340910699 in 1 BLISTER PACKHistorical
12634-910-711263409107130 in 1 BOTTLEHistorical
12634-910-741263409107424 in 1 BOTTLEHistorical
12634-910-781263409107828 in 1 BOTTLEHistorical
12634-910-791263409107925 in 1 BOTTLEHistorical
12634-910-801263409108020 in 1 BOTTLEHistorical
12634-910-811263409108121 in 1 BOTTLEHistorical
12634-910-821263409108212 in 1 BOTTLEHistorical
12634-910-841263409108414 in 1 BOTTLEHistorical
12634-910-851263409108515 in 1 BOTTLEHistorical
12634-910-901263409109090 in 1 BOTTLEHistorical
12634-910-91126340910911 in 1 BLISTER PACKHistorical
12634-910-92126340910922 in 1 BOTTLEHistorical
12634-910-93126340910933 in 1 BOTTLEHistorical
12634-910-94126340910944 in 1 BOTTLEHistorical
12634-910-95126340910955 in 1 BOTTLEHistorical
12634-910-96126340910966 in 1 BOTTLEHistorical
12634-910-97126340910977 in 1 BOTTLEHistorical
12634-910-98126340910988 in 1 BOTTLEHistorical
12634-910-99126340910999 in 1 BOTTLEHistorical