FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
50090-5998
11-digit product format
500905998
Labeler code
50090
Product ID
50090-5998_4ff9c176-ea18-430c-ba0e-3a17c3f898e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phentermine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA205019
Marketing category
ANDA
Marketing start
2017-01-24
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5998-0Phentermine Hydrochloride28 in 1 BOTTLECAPSULE288
50090-5998-2Phentermine Hydrochloride14 in 1 BOTTLECAPSULE148
50090-5998-4Phentermine Hydrochloride30 in 1 BOTTLECAPSULE308
50090-5998-5Phentermine Hydrochloride60 in 1 BOTTLECAPSULE608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5998-0EA - Each50090-5998ec51836c-278b-4bff-af78-345f2f05a5a912023-06-06
50090-5998-2EA - Each50090-5998ab5c2cbb-1ec7-4df7-aebb-0ace1a58f04612023-06-06
50090-5998-4EA - Each50090-59986c8b18f4-b855-410c-acb3-36e94f18272d12023-06-06
50090-5998-5EA - Each50090-5998b3ba3cbe-01b6-45b5-b6d0-1157a492878612023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5998PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 4 package rows20240608_c53bd3c5-01f6-4a21-9e3c-aa4969a01b4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSNc53bd3c5-01f6-4a21-9e3c-aa4969a01b4b8
968766phentermine hydrochloride 15 MG Oral CapsuleSCDc53bd3c5-01f6-4a21-9e3c-aa4969a01b4b8
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSYc53bd3c5-01f6-4a21-9e3c-aa4969a01b4b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5998-05009059980028 CAPSULE in 1 BOTTLE (50090-5998-0) 28 capsule2022-06-200000-00-00NoNoCurrent
50090-5998-25009059980214 CAPSULE in 1 BOTTLE (50090-5998-2) 14 capsule2022-06-200000-00-00NoNoCurrent
50090-5998-45009059980430 CAPSULE in 1 BOTTLE (50090-5998-4) 30 capsule2022-06-200000-00-00NoNoCurrent
50090-5998-55009059980560 CAPSULE in 1 BOTTLE (50090-5998-5) 60 capsule2022-06-200000-00-00NoNoCurrent