FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
10702-027
11-digit product format
107020027
Labeler code
10702
Product ID
10702-027_1662a72d-c285-b644-e063-6294a90a7333
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
ANDA040886
Marketing category
ANDA
Marketing start
2012-08-07
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui900038, 968766

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-027-01Phentermine Hydrochloride100 in 1 BOTTLECAPSULE1007
10702-027-03Phentermine Hydrochloride30 in 1 BOTTLECAPSULE307
10702-027-10Phentermine Hydrochloride1000 in 1 BOTTLECAPSULE10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-027-01EA - Each10702-02763e1e7f0-7c2c-4393-8286-3a2150849f0812013-02-13
10702-027-10EA - Each10702-027fd4b612c-2339-4d90-92d0-925f1d2f6da412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]2
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]2
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-027PHENTERMINE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]7Current NDC, Legacy NDC, 3 package rows20240420_b963f7bb-fa65-4e28-81c9-282fbe70a6a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN5234cabd-6b3e-404d-a0cd-256ee5fcc8f132
900038phentermine HCl 30 MG Oral CapsulePSN5234cabd-6b3e-404d-a0cd-256ee5fcc8f132
968766phentermine hydrochloride 15 MG Oral CapsuleSCD5234cabd-6b3e-404d-a0cd-256ee5fcc8f132
900038phentermine hydrochloride 30 MG Oral CapsuleSCD5234cabd-6b3e-404d-a0cd-256ee5fcc8f132
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY5234cabd-6b3e-404d-a0cd-256ee5fcc8f132
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY5234cabd-6b3e-404d-a0cd-256ee5fcc8f132
900038phentermine HCl 30 MG Oral CapsulePSN2abc445c-daa8-7326-e054-00144ff88e8812
900038phentermine hydrochloride 30 MG Oral CapsuleSCD2abc445c-daa8-7326-e054-00144ff88e8812
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY2abc445c-daa8-7326-e054-00144ff88e8812
900038phentermine HCl 30 MG Oral CapsulePSN680c1aba-760e-40a0-949d-b03448e1cf3a9
900038phentermine hydrochloride 30 MG Oral CapsuleSCD680c1aba-760e-40a0-949d-b03448e1cf3a9
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY680c1aba-760e-40a0-949d-b03448e1cf3a9
968766phentermine HCl 15 MG Oral CapsulePSNb963f7bb-fa65-4e28-81c9-282fbe70a6a67
900038phentermine HCl 30 MG Oral CapsulePSNb963f7bb-fa65-4e28-81c9-282fbe70a6a67
900038phentermine HCl 30 MG Oral CapsulePSN7f1c3a5d-dd9b-4441-a483-aa5777f8e40c7
968766phentermine hydrochloride 15 MG Oral CapsuleSCDb963f7bb-fa65-4e28-81c9-282fbe70a6a67
900038phentermine hydrochloride 30 MG Oral CapsuleSCDb963f7bb-fa65-4e28-81c9-282fbe70a6a67
900038phentermine hydrochloride 30 MG Oral CapsuleSCD7f1c3a5d-dd9b-4441-a483-aa5777f8e40c7
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSYb963f7bb-fa65-4e28-81c9-282fbe70a6a67
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY7f1c3a5d-dd9b-4441-a483-aa5777f8e40c7
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYb963f7bb-fa65-4e28-81c9-282fbe70a6a67
900038phentermine HCl 30 MG Oral CapsulePSN2f3b738f-d66b-40c1-8e69-bcd50bce3e472
900038phentermine HCl 30 MG Oral CapsulePSN1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd2
900038phentermine HCl 30 MG Oral CapsulePSN0ec83de8-0ee1-47e2-bfda-5bc724fd24432
900038phentermine HCl 30 MG Oral CapsulePSN0b4d847a-fcda-df31-e063-6294a90a0c5e2
900038phentermine HCl 30 MG Oral CapsulePSNf8e255d9-a538-4f8d-8837-0a7546ae82212
900038phentermine hydrochloride 30 MG Oral CapsuleSCDf8e255d9-a538-4f8d-8837-0a7546ae82212
900038phentermine hydrochloride 30 MG Oral CapsuleSCD2f3b738f-d66b-40c1-8e69-bcd50bce3e472
900038phentermine hydrochloride 30 MG Oral CapsuleSCD1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd2
900038phentermine hydrochloride 30 MG Oral CapsuleSCD0ec83de8-0ee1-47e2-bfda-5bc724fd24432
900038phentermine hydrochloride 30 MG Oral CapsuleSCD0b4d847a-fcda-df31-e063-6294a90a0c5e2
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY2f3b738f-d66b-40c1-8e69-bcd50bce3e472
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd2
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY0ec83de8-0ee1-47e2-bfda-5bc724fd24432
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYf8e255d9-a538-4f8d-8837-0a7546ae82212
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY0b4d847a-fcda-df31-e063-6294a90a0c5e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-027-0110702002701100 CAPSULE in 1 BOTTLE (10702-027-01) 100 capsule2012-08-070000-00-00NoNoCurrent
10702-027-031070200270330 CAPSULE in 1 BOTTLE (10702-027-03) 30 capsule2012-08-070000-00-00NoNoCurrent
10702-027-10107020027101000 CAPSULE in 1 BOTTLE (10702-027-10) 1000 capsule2012-08-070000-00-00NoNoCurrent