FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
71205-758
11-digit product format
712050758
Labeler code
71205
Product ID
71205-758_977886cf-5644-4484-85c5-ff415eb314f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040526
Marketing category
ANDA
Marketing start
2013-08-12
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
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV

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
71205-758-14Phentermine Hydrochloride14 in 1 BOTTLE, PLASTICTABLET142
71205-758-30Phentermine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
71205-758-60Phentermine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET602
71205-758-90Phentermine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-758-14EA - Each71205-758c9ca7026-47bc-47e5-8638-56a21efcbe1e12023-08-08
71205-758-30EA - Each71205-7587c812af4-946a-412f-82aa-5d69251373cb12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-758PHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]2Current NDC, 4 package rows20230520_b14a8f6a-a1c6-4104-80f2-0fa35320d04c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-758-147120507581414 TABLET in 1 BOTTLE, PLASTIC (71205-758-14) 14 tablet2023-05-05NoNoCurrent
71205-758-307120507583030 TABLET in 1 BOTTLE, PLASTIC (71205-758-30) 30 tablet2023-02-08NoNoCurrent
71205-758-607120507586060 TABLET in 1 BOTTLE, PLASTIC (71205-758-60) 60 tablet2023-02-08NoNoCurrent
71205-758-907120507589090 TABLET in 1 BOTTLE, PLASTIC (71205-758-90) 90 tablet2023-02-08NoNoCurrent