Phentermine Hydrochloride

Product NDC
50436-6746
11-digit product format
504366746
Labeler code
50436
Product ID
50436-6746_b8509f5f-1cf8-464c-8c59-ecfb131bc3f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA040875
Marketing category
ANDA
Marketing start
2012-08-07
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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
50436-6746-22024-07-30C16284748780-11030e365-4b58-111a-e063-dadaa90a10e2These 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
50436-6746-32024-07-30C16284748780-11030e365-3166-111a-e063-dadaa90a10e2These 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
50436-6746-22024-01-30C16284748780-11030e365-4b58-111a-e063-dadaa90a10e2These 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
50436-6746-32024-01-30C16284748780-11030e365-3166-111a-e063-dadaa90a10e2These 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
50436-6746-12021-01-29C16284748780-1ba0f9c33-30fc-a910-e053-dadaa90a0b85These 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
50436-6746-1Phentermine Hydrochloride28 in 1 BOTTLECAPSULE286
50436-6746-2Phentermine Hydrochloride28 in 1 BOTTLECAPSULE281
50436-6746-3Phentermine Hydrochloride21 in 1 BOTTLECAPSULE211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6746PHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]6Legacy NDC, 1 package rows20190531_f05537a9-1b2f-4e3a-a8b6-eb52dc22fc99.zip
50436-6746PHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES.]1Legacy NDC, 1 package rows20230928_7a8e685d-2f82-457b-ab95-e016db189c8f.zip
50436-6746PHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]1Legacy NDC, 1 package rows20230829_3be105f2-54d3-4fc3-a732-d5fda43a47cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSNf05537a9-1b2f-4e3a-a8b6-eb52dc22fc996
900038phentermine hydrochloride 30 MG Oral CapsuleSCDf05537a9-1b2f-4e3a-a8b6-eb52dc22fc996
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYf05537a9-1b2f-4e3a-a8b6-eb52dc22fc996
900038phentermine HCl 30 MG Oral CapsulePSN3be105f2-54d3-4fc3-a732-d5fda43a47cf1
900038phentermine HCl 30 MG Oral CapsulePSN7a8e685d-2f82-457b-ab95-e016db189c8f1
900038phentermine hydrochloride 30 MG Oral CapsuleSCD3be105f2-54d3-4fc3-a732-d5fda43a47cf1
900038phentermine hydrochloride 30 MG Oral CapsuleSCD7a8e685d-2f82-457b-ab95-e016db189c8f1
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY3be105f2-54d3-4fc3-a732-d5fda43a47cf1
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY7a8e685d-2f82-457b-ab95-e016db189c8f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-6746-15043667460128 in 1 BOTTLEHistorical
50436-6746-25043667460228 in 1 BOTTLEHistorical
50436-6746-35043667460321 in 1 BOTTLEHistorical