Phentermine Hydrochloride

Product NDC
33261-408
11-digit product format
332610408
Labeler code
33261
Product ID
33261-408_de1b0250-3018-48a3-a7f3-49639679a086
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA040887
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
33261-408-07Phentermine Hydrochloride07 in 1 BOTTLECAPSULE071
33261-408-08Phentermine Hydrochloride08 in 1 BOTTLECAPSULE081
33261-408-14Phentermine Hydrochloride14 in 1 BOTTLECAPSULE141
33261-408-15Phentermine Hydrochloride15 in 1 BOTTLECAPSULE151
33261-408-23Phentermine Hydrochloride23 in 1 BOTTLECAPSULE231
33261-408-28Phentermine Hydrochloride28 in 1 BOTTLECAPSULE281
33261-408-30Phentermine Hydrochloride30 in 1 BOTTLECAPSULE301
33261-408-40Phentermine Hydrochloride40 in 1 BOTTLECAPSULE401
33261-408-45Phentermine Hydrochloride45 in 1 BOTTLECAPSULE451
33261-408-60Phentermine Hydrochloride60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-408-07EA - Each33261-4088a63adfc-773f-47cc-8842-d51837b13c5112015-10-02
33261-408-14EA - Each33261-408e409097c-5c21-487c-8831-03a5b2df9fc412015-10-02
33261-408-28EA - Each33261-408a97507c6-85db-472d-ae4a-e1e28a4b9e3812015-10-02
33261-408-30EA - Each33261-4089336109e-d45b-4957-a2c3-758def33286112015-10-02

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
33261-408PHENTERMINE 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
33261-408-073326104080707 in 1 BOTTLEHistorical
33261-408-083326104080808 in 1 BOTTLEHistorical
33261-408-143326104081414 in 1 BOTTLEHistorical
33261-408-153326104081515 in 1 BOTTLEHistorical
33261-408-233326104082323 in 1 BOTTLEHistorical
33261-408-283326104082828 in 1 BOTTLEHistorical
33261-408-303326104083030 in 1 BOTTLEHistorical
33261-408-403326104084040 in 1 BOTTLEHistorical
33261-408-453326104084545 in 1 BOTTLEHistorical
33261-408-603326104086060 in 1 BOTTLEHistorical