FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
68094-802
11-digit product format
680940802
Labeler code
68094
Product ID
68094-802_050ea3a8-ebed-43e8-84c6-1285b5d92718
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Precision Dose Inc.
Application
ANDA202248
Marketing category
ANDA
Marketing start
2024-02-15
Marketing end
2028-04-30
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
15 mg/1
Pharmacologic classes
Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE15 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
68094-802-50Phentermine Hydrochloride100 in 1 BOTTLECAPSULE1003
68094-802-70Phentermine Hydrochloride1000 in 1 BOTTLECAPSULE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-802-50EA - Each68094-802ad998354-44d1-4bc8-bde2-ea915a7b5e7112024-04-05
68094-802-70EA - Each68094-802d8e826de-113f-4110-b56c-54397fc120f312024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-802PHENTERMINE HYDROCHLORIDE CAPSULE [PRECISION DOSE INC.]2Current NDC, 2 package rows20240215_095a2be5-721e-46e6-976f-9137c855cd22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSNe48feec6-50c9-4ccd-b9da-56956d14c853103
968766phentermine hydrochloride 15 MG Oral CapsuleSCDe48feec6-50c9-4ccd-b9da-56956d14c853103
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSYe48feec6-50c9-4ccd-b9da-56956d14c853103
968766phentermine HCl 15 MG Oral CapsulePSN095a2be5-721e-46e6-976f-9137c855cd223
900038phentermine HCl 30 MG Oral CapsulePSN095a2be5-721e-46e6-976f-9137c855cd223
968766phentermine hydrochloride 15 MG Oral CapsuleSCD095a2be5-721e-46e6-976f-9137c855cd223
900038phentermine hydrochloride 30 MG Oral CapsuleSCD095a2be5-721e-46e6-976f-9137c855cd223
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY095a2be5-721e-46e6-976f-9137c855cd223
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY095a2be5-721e-46e6-976f-9137c855cd223

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-802-5068094080250100 CAPSULE in 1 BOTTLE (68094-802-50) 100 capsule2024-02-152028-04-30NoNoHistorical
68094-802-70680940802701000 CAPSULE in 1 BOTTLE (68094-802-70) 1000 capsule2024-02-152028-04-30NoNoHistorical