FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
68071-3535
11-digit product format
680713535
Labeler code
68071
Product ID
68071-3535_2d3fa192-bcd3-7d2f-e063-6394a90aa73f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040886
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3535-32025-02-03C16284748780-12cef2736-59f9-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
68071-3535-32025-01-30C16284748780-12cef2736-59f9-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3535-3Phentermine Hydrochloride30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3535PHENTERMINE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250205_0b4d847a-fcda-df31-e063-6294a90a0c5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN0b4d847a-fcda-df31-e063-6294a90a0c5e2
900038phentermine hydrochloride 30 MG Oral CapsuleSCD0b4d847a-fcda-df31-e063-6294a90a0c5e2
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY0b4d847a-fcda-df31-e063-6294a90a0c5e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3535-36807135350330 CAPSULE in 1 BOTTLE (68071-3535-3) 30 capsule2023-11-29NoNoCurrent