FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
17224-851
11-digit product format
172240851
Labeler code
17224
Product ID
17224-851_f60149f4-c2a9-b4cf-e053-2995a90af524
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTERMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Calvin Scott & Co., Inc.
Application
ANDA205019
Marketing category
ANDA
Marketing start
2019-02-01
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
15 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui968766

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17224-851-282023-03-03C16284748780-1ba0f9c33-3eb2-a910-e053-dadaa90a0b85PHENTERMINE hydrochloride capsules USP, for oral use CIV These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. Initial U.S. Approval: 1959
17224-851-282023-03-03C16284748780-1ba0f9c33-3eb2-a910-e053-dadaa90a0b85PHENTERMINE hydrochloride capsules USP, for oral use CIV These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. Initial U.S. Approval: 1959
17224-851-282021-01-29C16284748780-1ba0f9c33-3eb2-a910-e053-dadaa90a0b85PHENTERMINE hydrochloride capsules USP, for oral use CIV These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. Initial U.S. Approval: 1959
17224-851-282021-01-29C16284748780-1ba0f9c33-3eb2-a910-e053-dadaa90a0b85PHENTERMINE hydrochloride capsules USP, for oral use CIV These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17224-851-21Phentermine Hydrochloride21 in 1 BOTTLECAPSULE212
17224-851-28Phentermine Hydrochloride28 in 1 BOTTLECAPSULE282
17224-851-30Phentermine Hydrochloride30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17224-851PHENTERMINE HYDROCHLORIDE CAPSULE [CALVIN SCOTT & CO., INC.]2Current NDC, Legacy NDC, 3 package rows20230306_d24aaa53-9c78-4c1b-9495-c785a9cf2b26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSNd24aaa53-9c78-4c1b-9495-c785a9cf2b263
968766phentermine hydrochloride 15 MG Oral CapsuleSCDd24aaa53-9c78-4c1b-9495-c785a9cf2b263
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSYd24aaa53-9c78-4c1b-9495-c785a9cf2b263

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17224-851-211722408512121 CAPSULE in 1 BOTTLE (17224-851-21) 21 capsule2022-04-14NoNoCurrent
17224-851-281722408512828 CAPSULE in 1 BOTTLE (17224-851-28) 28 capsule2022-04-14NoNoCurrent
17224-851-301722408513030 CAPSULE in 1 BOTTLE (17224-851-30) 30 capsule2022-04-14NoNoCurrent
17224-851-561722408515656 CAPSULE in 1 BOTTLE (17224-851-56)56 capsule2022-04-140Current
17224-851-601722408516060 CAPSULE in 1 BOTTLE (17224-851-60)60 capsule2022-04-140Current