Phentermine Hydrochloride

Product NDC
33261-471
11-digit product format
332610471
Labeler code
33261
Product ID
33261-471_de1b0250-3018-48a3-a7f3-49639679a086
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA040876
Marketing category
ANDA
Marketing start
2012-08-15
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
38 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
33261-471-07Phentermine Hydrochloride07 in 1 BOTTLETABLET071
33261-471-08Phentermine Hydrochloride08 in 1 BOTTLETABLET081
33261-471-14Phentermine Hydrochloride14 in 1 BOTTLETABLET141
33261-471-15Phentermine Hydrochloride15 in 1 BOTTLETABLET151
33261-471-23Phentermine Hydrochloride23 in 1 BOTTLETABLET231
33261-471-28Phentermine Hydrochloride28 in 1 BOTTLETABLET281
33261-471-30Phentermine Hydrochloride30 in 1 BOTTLETABLET301
33261-471-40Phentermine Hydrochloride40 in 1 BOTTLETABLET401
33261-471-45Phentermine Hydrochloride45 in 1 BOTTLETABLET451
33261-471-60Phentermine Hydrochloride60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-471-14EA - Each33261-471464ccd50-ece3-412e-8b44-3575a4ccb65412018-11-06
33261-471-15EA - Each33261-471f0a944e3-8462-424b-8679-8db2ff190eb212015-10-02
33261-471-23EA - Each33261-471ecc32137-f673-4232-9150-788e527c1e9712013-02-13
33261-471-28EA - Each33261-47152d498c7-b2d1-4567-9285-bc8ec010a80412015-10-02
33261-471-45EA - Each33261-471b969cdc1-e429-4cf6-9482-5879b13ce25112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-471PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 10 package rows20121007_e6ea6906-c4c9-4d59-9816-d2ffb1f042de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803348phentermine HCl 37.5 MG Oral CapsulePSNe6ea6906-c4c9-4d59-9816-d2ffb1f042de1
803353phentermine HCl 37.5 MG Oral TabletPSNe6ea6906-c4c9-4d59-9816-d2ffb1f042de1
803348phentermine hydrochloride 37.5 MG Oral CapsuleSCDe6ea6906-c4c9-4d59-9816-d2ffb1f042de1
803353phentermine hydrochloride 37.5 MG Oral TabletSCDe6ea6906-c4c9-4d59-9816-d2ffb1f042de1
803348phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral CapsuleSYe6ea6906-c4c9-4d59-9816-d2ffb1f042de1
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYe6ea6906-c4c9-4d59-9816-d2ffb1f042de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-471-073326104710707 in 1 BOTTLEHistorical
33261-471-083326104710808 in 1 BOTTLEHistorical
33261-471-143326104711414 in 1 BOTTLEHistorical
33261-471-153326104711515 in 1 BOTTLEHistorical
33261-471-233326104712323 in 1 BOTTLEHistorical
33261-471-283326104712828 in 1 BOTTLEHistorical
33261-471-303326104713030 in 1 BOTTLEHistorical
33261-471-403326104714040 in 1 BOTTLEHistorical
33261-471-453326104714545 in 1 BOTTLEHistorical
33261-471-603326104716060 in 1 BOTTLEHistorical