FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
72789-560
11-digit product format
727890560
Labeler code
72789
Product ID
72789-560_4f6c3636-135a-5b39-e063-6294a90a9310
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040190
Marketing category
ANDA
Marketing start
2014-05-01
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
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride
Listing expiration
2027-12-31

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
72789-560-28Phentermine Hydrochloride28 in 1 BOTTLE, PLASTICTABLET282
72789-560-30Phentermine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-560-28EA - Each72789-5609a59944a-ae8d-4bf2-b0ec-d93749ed272712026-05-22
72789-560-30EA - Each72789-5604ffe7833-6b94-436e-8216-b81b6375c0af12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNeae1d7f9-733c-434b-9199-5f7052e541da2
803353phentermine hydrochloride 37.5 MG Oral TabletSCDeae1d7f9-733c-434b-9199-5f7052e541da2
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYeae1d7f9-733c-434b-9199-5f7052e541da2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-560-287278905602828 TABLET in 1 BOTTLE, PLASTIC (72789-560-28) 28 tablet2026-04-14NoNoCurrent
72789-560-307278905603030 TABLET in 1 BOTTLE, PLASTIC (72789-560-30) 30 tablet2026-04-14NoNoCurrent