FDA.reportPublic FDA data

LOMAIRA

Product NDC
17224-840
11-digit product format
172240840
Labeler code
17224
Product ID
17224-840_3a71a481-2240-1de3-e063-6294a90aaf19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTERMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Calvin Scott & Co., Inc.
Application
ANDA203495
Marketing category
ANDA
Marketing start
2016-09-12
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
LOMAIRA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui826919, 1810304

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
17224-840-28LOMAIRA28 in 1 BOTTLETABLET282
17224-840-30LOMAIRA30 in 1 BOTTLETABLET302
17224-840-60LOMAIRA60 in 1 BOTTLETABLET602
17224-840-90LOMAIRA90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17224-840LOMAIRA (PHENTERMINE HYDROCHLORIDE) TABLET [CALVIN SCOTT & CO., INC.]1Current NDC, 4 package rows20230408_0718f0f3-77f2-45d7-be12-1ed718c8b806.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1810304Lomaira 8 MG Oral TabletPSN0718f0f3-77f2-45d7-be12-1ed718c8b8063
826919phentermine HCl 8 MG Oral TabletPSN0718f0f3-77f2-45d7-be12-1ed718c8b8063
1810304phentermine hydrochloride 8 MG Oral Tablet [Lomaira]SBD0718f0f3-77f2-45d7-be12-1ed718c8b8063
826919phentermine hydrochloride 8 MG Oral TabletSCD0718f0f3-77f2-45d7-be12-1ed718c8b8063
1810304Lomaira 8 MG (equivalent to phentermine 6.4 MG) Oral TabletSY0718f0f3-77f2-45d7-be12-1ed718c8b8063
1810304Lomaira 8 MG Oral TabletSY0718f0f3-77f2-45d7-be12-1ed718c8b8063
826919phentermine HCl 8 MG (equivalent to phentermine 6.4 MG) Oral TabletSY0718f0f3-77f2-45d7-be12-1ed718c8b8063

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17224-840-211722408402121 TABLET in 1 BOTTLE (17224-840-21)21 tablet2016-09-120Current
17224-840-281722408402828 TABLET in 1 BOTTLE (17224-840-28) 28 tablet2016-09-12NoNoCurrent
17224-840-301722408403030 TABLET in 1 BOTTLE (17224-840-30) 30 tablet2016-09-12NoNoCurrent
17224-840-421722408404242 TABLET in 1 BOTTLE (17224-840-42)42 tablet2016-09-120Current
17224-840-601722408406060 TABLET in 1 BOTTLE (17224-840-60) 60 tablet2016-09-12NoNoCurrent
17224-840-901722408409090 TABLET in 1 BOTTLE (17224-840-90) 90 tablet2016-09-12NoNoCurrent