FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
63629-8537
11-digit product format
636298537
Labeler code
63629
Product ID
63629-8537_f9bab520-7baa-4cec-84dd-c61d1a86a43d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phentermine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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

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
63629-8537-0Phentermine Hydrochloride28 in 1 BOTTLECAPSULE28103
63629-8537-1Phentermine Hydrochloride30 in 1 BOTTLECAPSULE30103
63629-8537-2Phentermine Hydrochloride7 in 1 BOTTLECAPSULE7103
63629-8537-3Phentermine Hydrochloride2 in 1 BOTTLECAPSULE2103
63629-8537-4Phentermine Hydrochloride60 in 1 BOTTLECAPSULE60103
63629-8537-5Phentermine Hydrochloride24 in 1 BOTTLECAPSULE24103
63629-8537-6Phentermine Hydrochloride14 in 1 BOTTLECAPSULE14103
63629-8537-7Phentermine Hydrochloride42 in 1 BOTTLECAPSULE42103
63629-8537-8Phentermine Hydrochloride21 in 1 BOTTLECAPSULE21103
63629-8537-9Phentermine Hydrochloride56 in 1 BOTTLECAPSULE56103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8537PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20230411_fe78b5b4-47bf-484b-ab37-e0d7de6fad57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSNfe78b5b4-47bf-484b-ab37-e0d7de6fad57103
900038phentermine hydrochloride 30 MG Oral CapsuleSCDfe78b5b4-47bf-484b-ab37-e0d7de6fad57103
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYfe78b5b4-47bf-484b-ab37-e0d7de6fad57103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8537-06362985370028 CAPSULE in 1 BOTTLE (63629-8537-0) 28 capsule2023-03-100000-00-00NoNoCurrent
63629-8537-16362985370130 CAPSULE in 1 BOTTLE (63629-8537-1) 30 capsule2023-03-100000-00-00NoNoCurrent
63629-8537-2636298537027 CAPSULE in 1 BOTTLE (63629-8537-2) 7 capsule2023-03-100000-00-00NoNoCurrent
63629-8537-3636298537032 CAPSULE in 1 BOTTLE (63629-8537-3) 2 capsule2021-06-300000-00-00NoNoCurrent
63629-8537-46362985370460 CAPSULE in 1 BOTTLE (63629-8537-4) 60 capsule2023-03-100000-00-00NoNoCurrent
63629-8537-56362985370524 CAPSULE in 1 BOTTLE (63629-8537-5) 24 capsule2023-03-100000-00-00NoNoCurrent
63629-8537-66362985370614 CAPSULE in 1 BOTTLE (63629-8537-6) 14 capsule2023-03-100000-00-00NoNoCurrent
63629-8537-76362985370742 CAPSULE in 1 BOTTLE (63629-8537-7) 42 capsule2023-03-100000-00-00NoNoCurrent
63629-8537-86362985370821 CAPSULE in 1 BOTTLE (63629-8537-8) 21 capsule2023-03-100000-00-00NoNoCurrent
63629-8537-96362985370956 CAPSULE in 1 BOTTLE (63629-8537-9) 56 capsule2023-03-100000-00-00NoNoCurrent