FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
10702-067
11-digit product format
107020067
Labeler code
10702
Product ID
10702-067_7d787b5e-b8c6-1ca4-e053-2991aa0a464b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
KVK-TECH, Inc.
Application
ANDA203436
Marketing category
ANDA
Marketing start
2018-03-29
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
8 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 HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui826919

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
10702-067-03Phentermine Hydrochloride30 in 1 BOTTLETABLET306
10702-067-05Phentermine Hydrochloride5000 in 1 BOTTLETABLET50006
10702-067-10Phentermine Hydrochloride1000 in 1 BOTTLETABLET10006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-067PHENTERMINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]6Current NDC, Legacy NDC, 3 package rows20181221_ff620c0b-aa99-4f63-9526-d094cedc8d19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
826919phentermine HCl 8 MG Oral TabletPSNff620c0b-aa99-4f63-9526-d094cedc8d196
826919phentermine hydrochloride 8 MG Oral TabletSCDff620c0b-aa99-4f63-9526-d094cedc8d196
826919phentermine HCl 8 MG (equivalent to phentermine 6.4 MG) Oral TabletSYff620c0b-aa99-4f63-9526-d094cedc8d196

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-067-031070200670330 TABLET in 1 BOTTLE (10702-067-03) 30 tablet2018-03-290000-00-00NoNoCurrent
10702-067-05107020067055000 TABLET in 1 BOTTLE (10702-067-05) 5000 tablet2018-03-290000-00-00NoNoCurrent
10702-067-10107020067101000 TABLET in 1 BOTTLE (10702-067-10) 1000 tablet2018-03-290000-00-00NoNoCurrent