Phentermine Hydrochloride

Product NDC
12634-516
11-digit product format
126340516
Labeler code
12634
Product ID
12634-516_3648073a-ac05-2c76-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA040875
Marketing category
ANDA
Marketing start
2012-08-07
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
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
12634-516-002021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-012021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-092021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-402021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-422021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-452021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-502021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-522021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-542021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-572021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-582021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-592021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-602021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-612021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-632021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-662021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-672021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-692021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-712021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-742021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-782021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-792021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-802021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-812021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-822021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-842021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-852021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-902021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-912021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-922021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-932021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-942021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-952021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-962021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-972021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-982021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg
12634-516-992021-01-29C16284748780-1ba0f9c33-406b-a910-e053-dadaa90a0b85Phentermine HCL 30 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-516-00Phentermine Hydrochloride10 in 1 BOTTLECAPSULE103
12634-516-01Phentermine Hydrochloride100 in 1 BOTTLECAPSULE1003
12634-516-09Phentermine Hydrochloride35 in 1 BOTTLECAPSULE353
12634-516-40Phentermine Hydrochloride40 in 1 BOTTLECAPSULE403
12634-516-42Phentermine Hydrochloride42 in 1 BOTTLECAPSULE423
12634-516-45Phentermine Hydrochloride45 in 1 BOTTLECAPSULE453
12634-516-50Phentermine Hydrochloride50 in 1 BOTTLECAPSULE503
12634-516-52Phentermine Hydrochloride12 in 1 BLISTER PACKCAPSULE123
12634-516-54Phentermine Hydrochloride14 in 1 BLISTER PACKCAPSULE143
12634-516-57Phentermine Hydrochloride20 in 1 BLISTER PACKCAPSULE203
12634-516-58Phentermine Hydrochloride28 in 1 BLISTER PACKCAPSULE283
12634-516-59Phentermine Hydrochloride30 in 1 BLISTER PACKCAPSULE303
12634-516-60Phentermine Hydrochloride60 in 1 BOTTLECAPSULE603
12634-516-61Phentermine Hydrochloride10 in 1 BLISTER PACKCAPSULE103
12634-516-63Phentermine Hydrochloride3 in 1 BLISTER PACKCAPSULE33
12634-516-66Phentermine Hydrochloride6 in 1 BLISTER PACKCAPSULE63
12634-516-67Phentermine Hydrochloride7 in 1 BLISTER PACKCAPSULE73
12634-516-69Phentermine Hydrochloride9 in 1 BLISTER PACKCAPSULE93
12634-516-71Phentermine Hydrochloride30 in 1 BOTTLECAPSULE303
12634-516-74Phentermine Hydrochloride24 in 1 BOTTLECAPSULE243
12634-516-78Phentermine Hydrochloride28 in 1 BOTTLECAPSULE283
12634-516-79Phentermine Hydrochloride25 in 1 BOTTLECAPSULE253
12634-516-80Phentermine Hydrochloride20 in 1 BOTTLECAPSULE203
12634-516-81Phentermine Hydrochloride21 in 1 BOTTLECAPSULE213
12634-516-82Phentermine Hydrochloride12 in 1 BOTTLECAPSULE123
12634-516-84Phentermine Hydrochloride14 in 1 BOTTLECAPSULE143
12634-516-85Phentermine Hydrochloride15 in 1 BOTTLECAPSULE153
12634-516-90Phentermine Hydrochloride90 in 1 BOTTLECAPSULE903
12634-516-91Phentermine Hydrochloride1 in 1 BLISTER PACKCAPSULE13
12634-516-92Phentermine Hydrochloride2 in 1 BOTTLECAPSULE23
12634-516-93Phentermine Hydrochloride3 in 1 BOTTLECAPSULE33
12634-516-94Phentermine Hydrochloride4 in 1 BOTTLECAPSULE43
12634-516-95Phentermine Hydrochloride5 in 1 BOTTLECAPSULE53
12634-516-96Phentermine Hydrochloride6 in 1 BOTTLECAPSULE63
12634-516-97Phentermine Hydrochloride7 in 1 BOTTLECAPSULE73
12634-516-98Phentermine Hydrochloride8 in 1 BOTTLECAPSULE83
12634-516-99Phentermine Hydrochloride9 in 1 BOTTLECAPSULE93

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-516PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA INC.]3Legacy NDC, 37 package rows20160629_d8ddc6a0-29d0-4730-b718-1bdb2937a91c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSNd8ddc6a0-29d0-4730-b718-1bdb2937a91c3
900038phentermine hydrochloride 30 MG Oral CapsuleSCDd8ddc6a0-29d0-4730-b718-1bdb2937a91c3
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYd8ddc6a0-29d0-4730-b718-1bdb2937a91c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-516-001263405160010 in 1 BOTTLEHistorical
12634-516-0112634051601100 in 1 BOTTLEHistorical
12634-516-091263405160935 in 1 BOTTLEHistorical
12634-516-401263405164040 in 1 BOTTLEHistorical
12634-516-421263405164242 in 1 BOTTLEHistorical
12634-516-451263405164545 in 1 BOTTLEHistorical
12634-516-501263405165050 in 1 BOTTLEHistorical
12634-516-521263405165212 in 1 BLISTER PACKHistorical
12634-516-541263405165414 in 1 BLISTER PACKHistorical
12634-516-571263405165720 in 1 BLISTER PACKHistorical
12634-516-581263405165828 in 1 BLISTER PACKHistorical
12634-516-591263405165930 in 1 BLISTER PACKHistorical
12634-516-601263405166060 in 1 BOTTLEHistorical
12634-516-611263405166110 in 1 BLISTER PACKHistorical
12634-516-63126340516633 in 1 BLISTER PACKHistorical
12634-516-66126340516666 in 1 BLISTER PACKHistorical
12634-516-67126340516677 in 1 BLISTER PACKHistorical
12634-516-69126340516699 in 1 BLISTER PACKHistorical
12634-516-711263405167130 in 1 BOTTLEHistorical
12634-516-741263405167424 in 1 BOTTLEHistorical
12634-516-781263405167828 in 1 BOTTLEHistorical
12634-516-791263405167925 in 1 BOTTLEHistorical
12634-516-801263405168020 in 1 BOTTLEHistorical
12634-516-811263405168121 in 1 BOTTLEHistorical
12634-516-821263405168212 in 1 BOTTLEHistorical
12634-516-841263405168414 in 1 BOTTLEHistorical
12634-516-851263405168515 in 1 BOTTLEHistorical
12634-516-901263405169090 in 1 BOTTLEHistorical
12634-516-91126340516911 in 1 BLISTER PACKHistorical
12634-516-92126340516922 in 1 BOTTLEHistorical
12634-516-93126340516933 in 1 BOTTLEHistorical
12634-516-94126340516944 in 1 BOTTLEHistorical
12634-516-95126340516955 in 1 BOTTLEHistorical
12634-516-96126340516966 in 1 BOTTLEHistorical
12634-516-97126340516977 in 1 BOTTLEHistorical
12634-516-98126340516988 in 1 BOTTLEHistorical
12634-516-99126340516999 in 1 BOTTLEHistorical