PHENTERMINE HCL

Product NDC
61919-316
11-digit product format
619190316
Labeler code
61919
Product ID
61919-316_c80d15e2-fc5d-8d53-e053-2a95a90a8d67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTERMINE HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040886
Marketing category
ANDA
Marketing start
2016-07-08
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
2022-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-316-07PHENTERMINE HCL7 in 1 BOTTLECAPSULE74
61919-316-14PHENTERMINE HCL14 in 1 BOTTLECAPSULE144
61919-316-30PHENTERMINE HCL30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-316-07EA - Each61919-3164dc0aadc-cfdb-4fb9-8369-dc44963860d912021-03-02
61919-316-14EA - Each61919-31659ccc2f4-0443-4bfd-8328-21b704e64d6012021-08-05
61919-316-30EA - Each61919-316dff6088e-e8b8-4973-b687-5da1ece6f06e12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-316PHENTERMINE HCL CAPSULE [DIRECT RX]4Legacy NDC, 3 package rows20230419_375bfe83-c893-3ea7-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN375bfe83-c893-3ea7-e054-00144ff88e884
968766phentermine hydrochloride 15 MG Oral CapsuleSCD375bfe83-c893-3ea7-e054-00144ff88e884
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY375bfe83-c893-3ea7-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-316-07619190316077 CAPSULE in 1 BOTTLE (61919-316-07) 7 capsule2016-07-080000-00-00NoNoCurrent
61919-316-146191903161414 CAPSULE in 1 BOTTLE (61919-316-14) 14 capsule2016-07-080000-00-00NoNoCurrent
61919-316-306191903163030 CAPSULE in 1 BOTTLE (61919-316-30) 30 capsule2016-07-080000-00-00NoNoCurrent