FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
12634-547
11-digit product format
126340547
Labeler code
12634
Product ID
12634-547_36970e45-4158-5b83-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA040525
Marketing category
ANDA
Marketing start
2003-10-23
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
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
12634-547-002020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-012020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-092020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-402020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-422020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-452020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-502020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-522020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-542020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-572020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-582020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-592020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-602020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-612020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-632020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-662020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-672020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-692020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-712020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-742020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-782020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-792020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-802020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-812020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-822020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-842020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-852020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-902020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-912020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-922020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-932020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-942020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-952020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-962020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-972020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-982020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959
12634-547-992020-01-31C16284748780-19d75b9d0-1615-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-547-00Phentermine Hydrochloride10 in 1 BOTTLECAPSULE101
12634-547-01Phentermine Hydrochloride100 in 1 BOTTLECAPSULE1001
12634-547-09Phentermine Hydrochloride35 in 1 BOTTLECAPSULE351
12634-547-40Phentermine Hydrochloride40 in 1 BOTTLECAPSULE401
12634-547-42Phentermine Hydrochloride42 in 1 BOTTLECAPSULE421
12634-547-45Phentermine Hydrochloride45 in 1 BOTTLECAPSULE451
12634-547-50Phentermine Hydrochloride50 in 1 BOTTLECAPSULE501
12634-547-52Phentermine Hydrochloride12 in 1 BLISTER PACKCAPSULE121
12634-547-54Phentermine Hydrochloride14 in 1 BLISTER PACKCAPSULE141
12634-547-57Phentermine Hydrochloride20 in 1 BLISTER PACKCAPSULE201
12634-547-58Phentermine Hydrochloride28 in 1 BLISTER PACKCAPSULE281
12634-547-59Phentermine Hydrochloride30 in 1 BLISTER PACKCAPSULE301
12634-547-60Phentermine Hydrochloride60 in 1 BOTTLECAPSULE601
12634-547-61Phentermine Hydrochloride10 in 1 BLISTER PACKCAPSULE101
12634-547-63Phentermine Hydrochloride3 in 1 BLISTER PACKCAPSULE31
12634-547-66Phentermine Hydrochloride6 in 1 BLISTER PACKCAPSULE61
12634-547-67Phentermine Hydrochloride7 in 1 BLISTER PACKCAPSULE71
12634-547-69Phentermine Hydrochloride9 in 1 BLISTER PACKCAPSULE91
12634-547-71Phentermine Hydrochloride30 in 1 BOTTLECAPSULE301
12634-547-74Phentermine Hydrochloride24 in 1 BOTTLECAPSULE241
12634-547-78Phentermine Hydrochloride28 in 1 BOTTLECAPSULE281
12634-547-79Phentermine Hydrochloride25 in 1 BOTTLECAPSULE251
12634-547-80Phentermine Hydrochloride20 in 1 BOTTLECAPSULE201
12634-547-81Phentermine Hydrochloride21 in 1 BOTTLECAPSULE211
12634-547-82Phentermine Hydrochloride12 in 1 BOTTLECAPSULE121
12634-547-84Phentermine Hydrochloride14 in 1 BOTTLECAPSULE141
12634-547-85Phentermine Hydrochloride15 in 1 BOTTLECAPSULE151
12634-547-90Phentermine Hydrochloride90 in 1 BOTTLECAPSULE901
12634-547-91Phentermine Hydrochloride1 in 1 BLISTER PACKCAPSULE11
12634-547-92Phentermine Hydrochloride2 in 1 BOTTLECAPSULE21
12634-547-93Phentermine Hydrochloride3 in 1 BOTTLECAPSULE31
12634-547-94Phentermine Hydrochloride4 in 1 BOTTLECAPSULE41
12634-547-95Phentermine Hydrochloride5 in 1 BOTTLECAPSULE51
12634-547-96Phentermine Hydrochloride6 in 1 BOTTLECAPSULE61
12634-547-97Phentermine Hydrochloride7 in 1 BOTTLECAPSULE71
12634-547-98Phentermine Hydrochloride8 in 1 BOTTLECAPSULE81
12634-547-99Phentermine Hydrochloride9 in 1 BOTTLECAPSULE91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-547PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA INC.]1Legacy NDC, 37 package rows20160702_36970e45-4157-5b83-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN36970e45-4157-5b83-e054-00144ff88e881
900038phentermine hydrochloride 30 MG Oral CapsuleSCD36970e45-4157-5b83-e054-00144ff88e881
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY36970e45-4157-5b83-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-547-001263405470010 in 1 BOTTLEHistorical
12634-547-0112634054701100 in 1 BOTTLEHistorical
12634-547-091263405470935 in 1 BOTTLEHistorical
12634-547-401263405474040 in 1 BOTTLEHistorical
12634-547-421263405474242 in 1 BOTTLEHistorical
12634-547-451263405474545 in 1 BOTTLEHistorical
12634-547-501263405475050 in 1 BOTTLEHistorical
12634-547-521263405475212 in 1 BLISTER PACKHistorical
12634-547-541263405475414 in 1 BLISTER PACKHistorical
12634-547-571263405475720 in 1 BLISTER PACKHistorical
12634-547-581263405475828 in 1 BLISTER PACKHistorical
12634-547-591263405475930 in 1 BLISTER PACKHistorical
12634-547-601263405476060 in 1 BOTTLEHistorical
12634-547-611263405476110 in 1 BLISTER PACKHistorical
12634-547-63126340547633 in 1 BLISTER PACKHistorical
12634-547-66126340547666 in 1 BLISTER PACKHistorical
12634-547-67126340547677 in 1 BLISTER PACKHistorical
12634-547-69126340547699 in 1 BLISTER PACKHistorical
12634-547-711263405477130 in 1 BOTTLEHistorical
12634-547-741263405477424 in 1 BOTTLEHistorical
12634-547-781263405477828 in 1 BOTTLEHistorical
12634-547-791263405477925 in 1 BOTTLEHistorical
12634-547-801263405478020 in 1 BOTTLEHistorical
12634-547-811263405478121 in 1 BOTTLEHistorical
12634-547-821263405478212 in 1 BOTTLEHistorical
12634-547-841263405478414 in 1 BOTTLEHistorical
12634-547-851263405478515 in 1 BOTTLEHistorical
12634-547-901263405479090 in 1 BOTTLEHistorical
12634-547-91126340547911 in 1 BLISTER PACKHistorical
12634-547-92126340547922 in 1 BOTTLEHistorical
12634-547-93126340547933 in 1 BOTTLEHistorical
12634-547-94126340547944 in 1 BOTTLEHistorical
12634-547-95126340547955 in 1 BOTTLEHistorical
12634-547-96126340547966 in 1 BOTTLEHistorical
12634-547-97126340547977 in 1 BOTTLEHistorical
12634-547-98126340547988 in 1 BOTTLEHistorical
12634-547-99126340547999 in 1 BOTTLEHistorical