FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
63187-987
11-digit product format
631870987
Labeler code
63187
Product ID
63187-987_f8e58aea-898e-441f-a256-2bfb18e7fc4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040875
Marketing category
ANDA
Marketing start
2012-08-07
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

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
63187-987-07Phentermine Hydrochloride07 in 1 BOTTLECAPSULE073
63187-987-30Phentermine Hydrochloride30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-987-30EA - Each63187-98767374d41-dcab-46f3-b3b2-17246b39eafb12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-987PHENTERMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 2 package rows20191105_f2da0b5a-c7d6-48c3-98e9-7c611eb6ff7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSNf2da0b5a-c7d6-48c3-98e9-7c611eb6ff7e3
900038phentermine hydrochloride 30 MG Oral CapsuleSCDf2da0b5a-c7d6-48c3-98e9-7c611eb6ff7e3
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYf2da0b5a-c7d6-48c3-98e9-7c611eb6ff7e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-987-07631870987077 CAPSULE in 1 BOTTLE (63187-987-07) 7 capsule2018-03-010000-00-00NoNoCurrent
63187-987-306318709873030 CAPSULE in 1 BOTTLE (63187-987-30) 30 capsule2018-03-010000-00-00NoNoCurrent