PHENTERMINE HYDROCHLORIDE

Product NDC
61919-557
11-digit product format
619190557
Labeler code
61919
Product ID
61919-557_8d4168dd-59fb-188d-e053-2995a90aab43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTERMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA087022
Marketing category
ANDA
Marketing start
2019-07-09
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
15 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
61919-557-302023-01-30C16284748780-1f386c64a-2c29-0266-e053-dadaa90a7c1aPHENTERMINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-557-30PHENTERMINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-557PHENTERMINE HYDROCHLORIDE CAPSULE [DIRECT_RX]1Legacy NDC, 1 package rows20190802_8d4168dd-59fa-188d-e053-2995a90aab43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN8d4168dd-59fa-188d-e053-2995a90aab431
968766phentermine hydrochloride 15 MG Oral CapsuleSCD8d4168dd-59fa-188d-e053-2995a90aab431
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY8d4168dd-59fa-188d-e053-2995a90aab431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-557-306191905573030 CAPSULE in 1 BOTTLE (61919-557-30) 30 capsule2019-07-090000-00-00NoNoCurrent