Phentermine Hydrochloride

Product NDC
76420-586
11-digit product format
764200586
Labeler code
76420
Product ID
76420-586_04472220-f8f9-1f1a-e063-6294a90a2bb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phentermine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA205019
Marketing category
ANDA
Marketing start
2017-01-24
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
Rxcui900038, 968766

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
76420-586-10Phentermine Hydrochloride100 in 1 BOTTLECAPSULE1001
76420-586-30Phentermine Hydrochloride30 in 1 BOTTLECAPSULE301
76420-586-60Phentermine Hydrochloride60 in 1 BOTTLECAPSULE601
76420-586-90Phentermine Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-586PHENTERMINE HYDROCHLORIDE CAPSULE [ASCLEMED USA, INC.]1Current NDC, 4 package rows20230902_22683183-a828-47a4-9e52-38175d7c6f21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN22683183-a828-47a4-9e52-38175d7c6f211
900038phentermine HCl 30 MG Oral CapsulePSN22683183-a828-47a4-9e52-38175d7c6f211
968766phentermine hydrochloride 15 MG Oral CapsuleSCD22683183-a828-47a4-9e52-38175d7c6f211
900038phentermine hydrochloride 30 MG Oral CapsuleSCD22683183-a828-47a4-9e52-38175d7c6f211
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY22683183-a828-47a4-9e52-38175d7c6f211
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY22683183-a828-47a4-9e52-38175d7c6f211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-586-1076420058610100 CAPSULE in 1 BOTTLE (76420-586-10) 100 capsule2023-09-01NoNoHistorical
76420-586-307642005863030 CAPSULE in 1 BOTTLE (76420-586-30) 30 capsule2023-09-01NoNoHistorical
76420-586-607642005866060 CAPSULE in 1 BOTTLE (76420-586-60) 60 capsule2023-09-01NoNoHistorical
76420-586-907642005869090 CAPSULE in 1 BOTTLE (76420-586-90) 90 capsule2023-09-01NoNoHistorical