FDA.reportPublic FDA data

Benzphetamine Hydrochloride

Product NDC
12634-118
11-digit product format
126340118
Labeler code
12634
Product ID
12634-118_46efec4f-f86d-0534-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzphetamine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA040747
Marketing category
ANDA
Marketing start
2010-09-07
Marketing end
0000-00-00
Substance
BENZPHETAMINE HYDROCHLORIDE
Active strength
50 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e1de3598-2dc1-55e2-fc07-ee2e74c73cfcProduct name320201013
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12634-118-002020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-012020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-092020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-122020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-182020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-402020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-422020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-452020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-502020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-522020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-542020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-572020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-592020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-602020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-612020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-632020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-662020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-672020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-692020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-712020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-742020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-782020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-792020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-802020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-812020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-822020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-842020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-852020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-902020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-912020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-922020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-932020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-942020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-952020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-962020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-972020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-982020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only
12634-118-992020-01-31C16284748780-19d75b9d0-191b-f424-e053-dadaa90a57ceRx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-118-00Benzphetamine Hydrochloride10 in 1 BOTTLETABLET105
12634-118-01Benzphetamine Hydrochloride100 in 1 BOTTLETABLET1005
12634-118-09Benzphetamine Hydrochloride35 in 1 BOTTLETABLET355
12634-118-12Benzphetamine Hydrochloride120 in 1 BOTTLETABLET1205
12634-118-18Benzphetamine Hydrochloride180 in 1 BOTTLETABLET1805
12634-118-40Benzphetamine Hydrochloride40 in 1 BOTTLETABLET405
12634-118-42Benzphetamine Hydrochloride42 in 1 BOTTLETABLET425
12634-118-45Benzphetamine Hydrochloride45 in 1 BOTTLETABLET455
12634-118-50Benzphetamine Hydrochloride50 in 1 BOTTLETABLET505
12634-118-52Benzphetamine Hydrochloride12 in 1 BLISTER PACKTABLET125
12634-118-54Benzphetamine Hydrochloride14 in 1 BLISTER PACKTABLET145
12634-118-57Benzphetamine Hydrochloride20 in 1 BLISTER PACKTABLET205
12634-118-59Benzphetamine Hydrochloride30 in 1 BLISTER PACKTABLET305
12634-118-60Benzphetamine Hydrochloride60 in 1 BOTTLETABLET605
12634-118-61Benzphetamine Hydrochloride10 in 1 BLISTER PACKTABLET105
12634-118-63Benzphetamine Hydrochloride3 in 1 BLISTER PACKTABLET35
12634-118-66Benzphetamine Hydrochloride6 in 1 BLISTER PACKTABLET65
12634-118-67Benzphetamine Hydrochloride7 in 1 BLISTER PACKTABLET75
12634-118-69Benzphetamine Hydrochloride9 in 1 BLISTER PACKTABLET95
12634-118-71Benzphetamine Hydrochloride30 in 1 BOTTLETABLET305
12634-118-74Benzphetamine Hydrochloride24 in 1 BOTTLETABLET245
12634-118-78Benzphetamine Hydrochloride28 in 1 BOTTLETABLET285
12634-118-79Benzphetamine Hydrochloride25 in 1 BOTTLETABLET255
12634-118-80Benzphetamine Hydrochloride20 in 1 BOTTLETABLET205
12634-118-81Benzphetamine Hydrochloride21 in 1 BOTTLETABLET215
12634-118-82Benzphetamine Hydrochloride12 in 1 BOTTLETABLET125
12634-118-84Benzphetamine Hydrochloride14 in 1 BOTTLETABLET145
12634-118-85Benzphetamine Hydrochloride15 in 1 BOTTLETABLET155
12634-118-90Benzphetamine Hydrochloride90 in 1 BOTTLETABLET905
12634-118-91Benzphetamine Hydrochloride1 in 1 BLISTER PACKTABLET15
12634-118-92Benzphetamine Hydrochloride2 in 1 BOTTLETABLET25
12634-118-93Benzphetamine Hydrochloride3 in 1 BOTTLETABLET35
12634-118-94Benzphetamine Hydrochloride4 in 1 BOTTLETABLET45
12634-118-95Benzphetamine Hydrochloride95 in 1 BOTTLETABLET955
12634-118-96Benzphetamine Hydrochloride6 in 1 BOTTLETABLET65
12634-118-97Benzphetamine Hydrochloride7 in 1 BOTTLETABLET75
12634-118-98Benzphetamine Hydrochloride8 in 1 BOTTLETABLET85
12634-118-99Benzphetamine Hydrochloride9 in 1 BOTTLETABLET95

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZPHETAMINE HYDROCHLORIDEACTIVE INGREDIENT43DWT87QT7BENZPHETAMINE HYDROCHLORIDE (BENAPHETAMINE) TABLET [APOTHECA INC.]3
BENZPHETAMINEACTIVE MOIETY0M3S43XK27BENZPHETAMINE HYDROCHLORIDE (BENAPHETAMINE) TABLET [APOTHECA INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBENZPHETAMINE HYDROCHLORIDE (BENAPHETAMINE) TABLET [APOTHECA INC.]3
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LBENZPHETAMINE HYDROCHLORIDE (BENAPHETAMINE) TABLET [APOTHECA INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BENZPHETAMINE HYDROCHLORIDE (BENAPHETAMINE) TABLET [APOTHECA INC.]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ABENZPHETAMINE HYDROCHLORIDE (BENAPHETAMINE) TABLET [APOTHECA INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RBENZPHETAMINE HYDROCHLORIDE (BENAPHETAMINE) TABLET [APOTHECA INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-118BENZPHETAMINE HYDROCHLORIDE TABLET [APOTHECA INC.]5Legacy NDC, 38 package rows20170126_e95dfb31-8365-498d-91ea-79738033f905.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904368benzphetamine HCl 50 MG Oral TabletPSNe95dfb31-8365-498d-91ea-79738033f9055
904368benzphetamine hydrochloride 50 MG Oral TabletSCDe95dfb31-8365-498d-91ea-79738033f9055

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-118-001263401180010 in 1 BOTTLEHistorical
12634-118-0112634011801100 in 1 BOTTLEHistorical
12634-118-091263401180935 in 1 BOTTLEHistorical
12634-118-1212634011812120 in 1 BOTTLEHistorical
12634-118-1812634011818180 in 1 BOTTLEHistorical
12634-118-401263401184040 in 1 BOTTLEHistorical
12634-118-421263401184242 in 1 BOTTLEHistorical
12634-118-451263401184545 in 1 BOTTLEHistorical
12634-118-501263401185050 in 1 BOTTLEHistorical
12634-118-521263401185212 in 1 BLISTER PACKHistorical
12634-118-541263401185414 in 1 BLISTER PACKHistorical
12634-118-571263401185720 in 1 BLISTER PACKHistorical
12634-118-591263401185930 in 1 BLISTER PACKHistorical
12634-118-601263401186060 in 1 BOTTLEHistorical
12634-118-611263401186110 in 1 BLISTER PACKHistorical
12634-118-63126340118633 in 1 BLISTER PACKHistorical
12634-118-66126340118666 in 1 BLISTER PACKHistorical
12634-118-67126340118677 in 1 BLISTER PACKHistorical
12634-118-69126340118699 in 1 BLISTER PACKHistorical
12634-118-711263401187130 in 1 BOTTLEHistorical
12634-118-741263401187424 in 1 BOTTLEHistorical
12634-118-781263401187828 in 1 BOTTLEHistorical
12634-118-791263401187925 in 1 BOTTLEHistorical
12634-118-801263401188020 in 1 BOTTLEHistorical
12634-118-811263401188121 in 1 BOTTLEHistorical
12634-118-821263401188212 in 1 BOTTLEHistorical
12634-118-841263401188414 in 1 BOTTLEHistorical
12634-118-851263401188515 in 1 BOTTLEHistorical
12634-118-901263401189090 in 1 BOTTLEHistorical
12634-118-91126340118911 in 1 BLISTER PACKHistorical
12634-118-92126340118922 in 1 BOTTLEHistorical
12634-118-93126340118933 in 1 BOTTLEHistorical
12634-118-94126340118944 in 1 BOTTLEHistorical
12634-118-951263401189595 in 1 BOTTLEHistorical
12634-118-96126340118966 in 1 BOTTLEHistorical
12634-118-97126340118977 in 1 BOTTLEHistorical
12634-118-98126340118988 in 1 BOTTLEHistorical
12634-118-99126340118999 in 1 BOTTLEHistorical