Phentermine Hydrochloride

Product NDC
33261-366
11-digit product format
332610366
Labeler code
33261
Product ID
33261-366_5f577a31-f2d5-4439-88be-f3cac906776c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
E
Listing certified through
2018-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-366-07Phentermine Hydrochloride7 in 1 BOTTLECAPSULE71
33261-366-08Phentermine Hydrochloride8 in 1 BOTTLECAPSULE81
33261-366-14Phentermine Hydrochloride14 in 1 BOTTLECAPSULE141
33261-366-15Phentermine Hydrochloride15 in 1 BOTTLECAPSULE151
33261-366-23Phentermine Hydrochloride23 in 1 BOTTLECAPSULE231
33261-366-28Phentermine Hydrochloride28 in 1 BOTTLECAPSULE281
33261-366-30Phentermine Hydrochloride30 in 1 BOTTLECAPSULE301
33261-366-40Phentermine Hydrochloride40 in 1 BOTTLECAPSULE401
33261-366-45Phentermine Hydrochloride45 in 1 BOTTLECAPSULE451
33261-366-60Phentermine Hydrochloride60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-366-07EA - Each33261-3662c69d813-4fd2-4f91-9173-634f660687bf12015-10-02
33261-366-14EA - Each33261-366a3ffc876-c0da-43ca-bfed-c7865b2bf67d12015-10-02
33261-366-28EA - Each33261-366b8019041-3e8f-4d37-8a29-abc86d8118e212015-10-02
33261-366-30EA - Each33261-366118cebef-4f41-45c7-a767-e6652fa385f812016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-366PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 10 package rows20121007_792831e9-ce9d-4d2d-ad98-80869c4c163f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN792831e9-ce9d-4d2d-ad98-80869c4c163f1
900038phentermine HCl 30 MG Oral CapsulePSN792831e9-ce9d-4d2d-ad98-80869c4c163f1
968766phentermine hydrochloride 15 MG Oral CapsuleSCD792831e9-ce9d-4d2d-ad98-80869c4c163f1
900038phentermine hydrochloride 30 MG Oral CapsuleSCD792831e9-ce9d-4d2d-ad98-80869c4c163f1
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY792831e9-ce9d-4d2d-ad98-80869c4c163f1
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY792831e9-ce9d-4d2d-ad98-80869c4c163f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-366-07332610366077 in 1 BOTTLEHistorical
33261-366-08332610366088 in 1 BOTTLEHistorical
33261-366-143326103661414 in 1 BOTTLEHistorical
33261-366-153326103661515 in 1 BOTTLEHistorical
33261-366-233326103662323 in 1 BOTTLEHistorical
33261-366-283326103662828 in 1 BOTTLEHistorical
33261-366-303326103663030 in 1 BOTTLEHistorical
33261-366-403326103664040 in 1 BOTTLEHistorical
33261-366-453326103664545 in 1 BOTTLEHistorical
33261-366-603326103666060 in 1 BOTTLEHistorical