FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
72789-470
11-digit product format
727890470
Labeler code
72789
Product ID
72789-470_4db3b822-949a-c929-e063-6394a90aee07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA202248
Marketing category
ANDA
Marketing start
2024-02-15
Marketing end
2028-04-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui900038

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
72789-470-07Phentermine Hydrochloride7 in 1 BOTTLE, PLASTICCAPSULE77
72789-470-14Phentermine Hydrochloride14 in 1 BOTTLE, PLASTICCAPSULE147
72789-470-21Phentermine Hydrochloride21 in 1 BOTTLE, PLASTICCAPSULE217
72789-470-30Phentermine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-470PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]6Current NDC, 4 package rows20250226_b425840f-380e-42bd-852a-6ee3641977ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSNb425840f-380e-42bd-852a-6ee3641977ce7
900038phentermine hydrochloride 30 MG Oral CapsuleSCDb425840f-380e-42bd-852a-6ee3641977ce7
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYb425840f-380e-42bd-852a-6ee3641977ce7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-470-07727890470077 CAPSULE in 1 BOTTLE, PLASTIC (72789-470-07) 7 capsule2025-01-132028-04-30NoNoHistorical
72789-470-147278904701414 CAPSULE in 1 BOTTLE, PLASTIC (72789-470-14) 14 capsule2025-02-102028-04-30NoNoHistorical
72789-470-217278904702121 CAPSULE in 1 BOTTLE, PLASTIC (72789-470-21) 21 capsule2025-02-052028-04-30NoNoHistorical
72789-470-307278904703030 CAPSULE in 1 BOTTLE, PLASTIC (72789-470-30) 30 capsule2025-02-242028-04-30NoNoHistorical