FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
12634-552
11-digit product format
126340552
Labeler code
12634
Product ID
12634-552_36d2ea29-459a-6ac9-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA040886
Marketing category
ANDA
Marketing start
2012-08-07
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
15 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
2020-12-31
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
12634-552-002021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-012021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-092021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-402021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-422021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-452021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-502021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-522021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-542021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-572021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-582021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-592021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-602021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-612021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-632021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-662021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-672021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-692021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-712021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-742021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-782021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-792021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-802021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-812021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-822021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-842021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-852021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-902021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-912021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-922021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-932021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-942021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-952021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-962021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-972021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-982021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-992021-01-29C16284748780-1ba0f9c33-2c0a-a910-e053-dadaa90a0b8536d2ea29-4599-6ac9-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-552-00Phentermine Hydrochloride10 in 1 BOTTLECAPSULE102
12634-552-01Phentermine Hydrochloride100 in 1 BOTTLECAPSULE1002
12634-552-09Phentermine Hydrochloride35 in 1 BOTTLECAPSULE352
12634-552-40Phentermine Hydrochloride40 in 1 BOTTLECAPSULE402
12634-552-42Phentermine Hydrochloride42 in 1 BOTTLECAPSULE422
12634-552-45Phentermine Hydrochloride45 in 1 BOTTLECAPSULE452
12634-552-50Phentermine Hydrochloride50 in 1 BOTTLECAPSULE502
12634-552-52Phentermine Hydrochloride12 in 1 BLISTER PACKCAPSULE122
12634-552-54Phentermine Hydrochloride14 in 1 BLISTER PACKCAPSULE142
12634-552-57Phentermine Hydrochloride20 in 1 BLISTER PACKCAPSULE202
12634-552-58Phentermine Hydrochloride28 in 1 BLISTER PACKCAPSULE282
12634-552-59Phentermine Hydrochloride30 in 1 BLISTER PACKCAPSULE302
12634-552-60Phentermine Hydrochloride60 in 1 BOTTLECAPSULE602
12634-552-61Phentermine Hydrochloride10 in 1 BLISTER PACKCAPSULE102
12634-552-63Phentermine Hydrochloride3 in 1 BLISTER PACKCAPSULE32
12634-552-66Phentermine Hydrochloride6 in 1 BLISTER PACKCAPSULE62
12634-552-67Phentermine Hydrochloride7 in 1 BLISTER PACKCAPSULE72
12634-552-69Phentermine Hydrochloride9 in 1 BLISTER PACKCAPSULE92
12634-552-71Phentermine Hydrochloride30 in 1 BOTTLECAPSULE302
12634-552-74Phentermine Hydrochloride24 in 1 BOTTLECAPSULE242
12634-552-78Phentermine Hydrochloride28 in 1 BOTTLECAPSULE282
12634-552-79Phentermine Hydrochloride25 in 1 BOTTLECAPSULE252
12634-552-80Phentermine Hydrochloride20 in 1 BOTTLECAPSULE202
12634-552-81Phentermine Hydrochloride21 in 1 BOTTLECAPSULE212
12634-552-82Phentermine Hydrochloride12 in 1 BOTTLECAPSULE122
12634-552-84Phentermine Hydrochloride14 in 1 BOTTLECAPSULE142
12634-552-85Phentermine Hydrochloride15 in 1 BOTTLECAPSULE152
12634-552-90Phentermine Hydrochloride90 in 1 BOTTLECAPSULE902
12634-552-91Phentermine Hydrochloride1 in 1 BLISTER PACKCAPSULE12
12634-552-92Phentermine Hydrochloride2 in 1 BOTTLECAPSULE22
12634-552-93Phentermine Hydrochloride3 in 1 BOTTLECAPSULE32
12634-552-94Phentermine Hydrochloride4 in 1 BOTTLECAPSULE42
12634-552-95Phentermine Hydrochloride5 in 1 BOTTLECAPSULE52
12634-552-96Phentermine Hydrochloride6 in 1 BOTTLECAPSULE62
12634-552-97Phentermine Hydrochloride7 in 1 BOTTLECAPSULE72
12634-552-98Phentermine Hydrochloride8 in 1 BOTTLECAPSULE82
12634-552-99Phentermine Hydrochloride9 in 1 BOTTLECAPSULE92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-552PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA INC.]2Legacy NDC, 37 package rows20160706_36d2ea29-4599-6ac9-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN36d2ea29-4599-6ac9-e054-00144ff88e882
968766phentermine hydrochloride 15 MG Oral CapsuleSCD36d2ea29-4599-6ac9-e054-00144ff88e882
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY36d2ea29-4599-6ac9-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-552-001263405520010 in 1 BOTTLEHistorical
12634-552-0112634055201100 in 1 BOTTLEHistorical
12634-552-091263405520935 in 1 BOTTLEHistorical
12634-552-401263405524040 in 1 BOTTLEHistorical
12634-552-421263405524242 in 1 BOTTLEHistorical
12634-552-451263405524545 in 1 BOTTLEHistorical
12634-552-501263405525050 in 1 BOTTLEHistorical
12634-552-521263405525212 in 1 BLISTER PACKHistorical
12634-552-541263405525414 in 1 BLISTER PACKHistorical
12634-552-571263405525720 in 1 BLISTER PACKHistorical
12634-552-581263405525828 in 1 BLISTER PACKHistorical
12634-552-591263405525930 in 1 BLISTER PACKHistorical
12634-552-601263405526060 in 1 BOTTLEHistorical
12634-552-611263405526110 in 1 BLISTER PACKHistorical
12634-552-63126340552633 in 1 BLISTER PACKHistorical
12634-552-66126340552666 in 1 BLISTER PACKHistorical
12634-552-67126340552677 in 1 BLISTER PACKHistorical
12634-552-69126340552699 in 1 BLISTER PACKHistorical
12634-552-711263405527130 in 1 BOTTLEHistorical
12634-552-741263405527424 in 1 BOTTLEHistorical
12634-552-781263405527828 in 1 BOTTLEHistorical
12634-552-791263405527925 in 1 BOTTLEHistorical
12634-552-801263405528020 in 1 BOTTLEHistorical
12634-552-811263405528121 in 1 BOTTLEHistorical
12634-552-821263405528212 in 1 BOTTLEHistorical
12634-552-841263405528414 in 1 BOTTLEHistorical
12634-552-851263405528515 in 1 BOTTLEHistorical
12634-552-901263405529090 in 1 BOTTLEHistorical
12634-552-91126340552911 in 1 BLISTER PACKHistorical
12634-552-92126340552922 in 1 BOTTLEHistorical
12634-552-93126340552933 in 1 BOTTLEHistorical
12634-552-94126340552944 in 1 BOTTLEHistorical
12634-552-95126340552955 in 1 BOTTLEHistorical
12634-552-96126340552966 in 1 BOTTLEHistorical
12634-552-97126340552977 in 1 BOTTLEHistorical
12634-552-98126340552988 in 1 BOTTLEHistorical
12634-552-99126340552999 in 1 BOTTLEHistorical