FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
71335-0564
11-digit product format
713350564
Labeler code
71335
Product ID
71335-0564_581321c1-c496-4931-92e3-6fe7e3e965be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-0564-1Phentermine Hydrochloride30 in 1 BOTTLECAPSULE307
71335-0564-2Phentermine Hydrochloride7 in 1 BOTTLECAPSULE77
71335-0564-3Phentermine Hydrochloride42 in 1 BOTTLECAPSULE427
71335-0564-4Phentermine Hydrochloride28 in 1 BOTTLECAPSULE287
71335-0564-5Phentermine Hydrochloride60 in 1 BOTTLECAPSULE607
71335-0564-6Phentermine Hydrochloride14 in 1 BOTTLECAPSULE147
71335-0564-7Phentermine Hydrochloride21 in 1 BOTTLECAPSULE217
71335-0564-8Phentermine Hydrochloride90 in 1 BOTTLECAPSULE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0564PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 8 package rows20240601_7f1c3a5d-dd9b-4441-a483-aa5777f8e40c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN7f1c3a5d-dd9b-4441-a483-aa5777f8e40c7
900038phentermine hydrochloride 30 MG Oral CapsuleSCD7f1c3a5d-dd9b-4441-a483-aa5777f8e40c7
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY7f1c3a5d-dd9b-4441-a483-aa5777f8e40c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0564-17133505640130 CAPSULE in 1 BOTTLE (71335-0564-1) 30 capsule2018-02-230000-00-00NoNoCurrent
71335-0564-2713350564027 CAPSULE in 1 BOTTLE (71335-0564-2) 7 capsule2018-03-060000-00-00NoNoCurrent
71335-0564-37133505640342 CAPSULE in 1 BOTTLE (71335-0564-3) 42 capsule2024-05-290000-00-00NoNoCurrent
71335-0564-47133505640428 CAPSULE in 1 BOTTLE (71335-0564-4) 28 capsule2019-02-270000-00-00NoNoCurrent
71335-0564-57133505640560 CAPSULE in 1 BOTTLE (71335-0564-5) 60 capsule2019-03-280000-00-00NoNoCurrent
71335-0564-67133505640614 CAPSULE in 1 BOTTLE (71335-0564-6) 14 capsule2018-02-050000-00-00NoNoCurrent
71335-0564-77133505640721 CAPSULE in 1 BOTTLE (71335-0564-7) 21 capsule2024-05-290000-00-00NoNoCurrent
71335-0564-87133505640890 CAPSULE in 1 BOTTLE (71335-0564-8) 90 capsule2024-05-290000-00-00NoNoCurrent