FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
63187-800
11-digit product format
631870800
Labeler code
63187
Product ID
63187-800_4e1cdc95-3d6c-4a43-8aec-194daf2abd12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203068
Marketing category
ANDA
Marketing start
2011-06-10
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
37.5 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 HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui803353

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
63187-800-07Phentermine Hydrochloride7 in 1 BOTTLETABLET76
63187-800-14Phentermine Hydrochloride14 in 1 BOTTLETABLET146
63187-800-15Phentermine Hydrochloride15 in 1 BOTTLETABLET156
63187-800-30Phentermine Hydrochloride30 in 1 BOTTLETABLET306
63187-800-60Phentermine Hydrochloride60 in 1 BOTTLETABLET606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-800-07EA - Each63187-8004c0c6240-6b75-4daf-8051-10b5690961ca12017-03-06
63187-800-14EA - Each63187-80065795f01-13a1-4c46-9d10-8ff9e8ef14f912021-10-08
63187-800-15EA - Each63187-800f5cecf87-e69d-4887-b0ff-4a79c3b836ca12018-05-09
63187-800-30EA - Each63187-80001bb4c80-fe04-4b8e-84f3-5bf61dd243a412017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-800PHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 5 package rows20220420_b3c48b3c-fab7-4ea4-93b0-b108979e9da3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNb3c48b3c-fab7-4ea4-93b0-b108979e9da36
803353phentermine hydrochloride 37.5 MG Oral TabletSCDb3c48b3c-fab7-4ea4-93b0-b108979e9da36
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYb3c48b3c-fab7-4ea4-93b0-b108979e9da36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-800-07631870800077 TABLET in 1 BOTTLE (63187-800-07) 7 tablet2017-01-020000-00-00NoNoCurrent
63187-800-146318708001414 TABLET in 1 BOTTLE (63187-800-14) 14 tablet2021-06-290000-00-00NoNoCurrent
63187-800-156318708001515 TABLET in 1 BOTTLE (63187-800-15) 15 tablet2017-01-020000-00-00NoNoCurrent
63187-800-306318708003030 TABLET in 1 BOTTLE (63187-800-30) 30 tablet2017-01-020000-00-00NoNoCurrent
63187-800-606318708006060 TABLET in 1 BOTTLE (63187-800-60) 60 tablet2017-01-020000-00-00NoNoCurrent