FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
68094-702
11-digit product format
680940702
Labeler code
68094
Product ID
68094-702_f245e2f3-2d40-468d-85f2-2fd47d2883d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Precision Dose Inc.
Application
ANDA200272
Marketing category
ANDA
Marketing start
2024-02-15
Marketing end
2028-04-30
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
37.5 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 HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui803353

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
68094-702-50Phentermine Hydrochloride100 in 1 BOTTLETABLET1003
68094-702-70Phentermine Hydrochloride1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-702-70EA - Each68094-702e4be69e9-64bb-4513-b75e-052a1bbcf34912024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-702PHENTERMINE HYDROCHLORIDE TABLET [PRECISION DOSE INC.]2Current NDC, 2 package rows20240215_8d5697b9-02e8-40c4-97c7-761d635243c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN8d5697b9-02e8-40c4-97c7-761d635243c83
803353phentermine hydrochloride 37.5 MG Oral TabletSCD8d5697b9-02e8-40c4-97c7-761d635243c83
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY8d5697b9-02e8-40c4-97c7-761d635243c83
803353phentermine HCl 37.5 MG Oral TabletPSNe6939fcf-3db2-492a-99ed-a384cdeea7a22
803353phentermine HCl 37.5 MG Oral TabletPSNf3b43443-dcf3-4a0d-a919-1be1bb9495ed2
803353phentermine hydrochloride 37.5 MG Oral TabletSCDe6939fcf-3db2-492a-99ed-a384cdeea7a22
803353phentermine hydrochloride 37.5 MG Oral TabletSCDf3b43443-dcf3-4a0d-a919-1be1bb9495ed2
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYe6939fcf-3db2-492a-99ed-a384cdeea7a22
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYf3b43443-dcf3-4a0d-a919-1be1bb9495ed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-702-5068094070250100 TABLET in 1 BOTTLE (68094-702-50) 100 tablet2024-02-152028-04-30NoNoHistorical
68094-702-70680940702701000 TABLET in 1 BOTTLE (68094-702-70) 1000 tablet2024-02-152028-04-30NoNoHistorical