FDA.reportPublic FDA data

LOMAIRA

Product NDC
10702-001
11-digit product format
107020001
Labeler code
10702
Product ID
10702-001_0ce01306-ef7f-563f-e063-6394a90a52b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
KVK-TECH, 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
2026-12-31

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
10702-001-03LOMAIRA30 in 1 BOTTLETABLET307
10702-001-06LOMAIRA60 in 1 BOTTLETABLET607
10702-001-09LOMAIRA90 in 1 BOTTLETABLET907
10702-001-10LOMAIRA1000 in 1 BOTTLETABLET10007
10702-001-25LOMAIRA250 in 1 BOTTLETABLET2507
10702-001-50LOMAIRA500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-001-09EA - Each10702-001838594d4-ccb4-474c-a02a-81296ada66ea12016-10-06
10702-001-25EA - Each10702-00195851c2d-e30b-4ce2-9dfa-b6c15ccbe07812022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-001LOMAIRA (PHENTERMINE HYDROCHLORIDE) TABLET [KVK-TECH, INC.]7Current NDC, Legacy NDC, 6 package rows20231220_cde9fb09-e5af-434d-8874-e4f9f974d893.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1810304Lomaira 8 MG Oral TabletPSNcde9fb09-e5af-434d-8874-e4f9f974d8937
826919phentermine HCl 8 MG Oral TabletPSNcde9fb09-e5af-434d-8874-e4f9f974d8937
1810304phentermine hydrochloride 8 MG Oral Tablet [Lomaira]SBDcde9fb09-e5af-434d-8874-e4f9f974d8937
826919phentermine hydrochloride 8 MG Oral TabletSCDcde9fb09-e5af-434d-8874-e4f9f974d8937
1810304Lomaira 8 MG (equivalent to phentermine 6.4 MG) Oral TabletSYcde9fb09-e5af-434d-8874-e4f9f974d8937
1810304Lomaira 8 MG Oral TabletSYcde9fb09-e5af-434d-8874-e4f9f974d8937
826919phentermine HCl 8 MG (equivalent to phentermine 6.4 MG) Oral TabletSYcde9fb09-e5af-434d-8874-e4f9f974d8937
1810304Lomaira 8 MG Oral TabletPSN329da53b-6f26-4590-be0d-2f20b0ab7b846
826919phentermine HCl 8 MG Oral TabletPSN329da53b-6f26-4590-be0d-2f20b0ab7b846
1810304phentermine hydrochloride 8 MG Oral Tablet [Lomaira]SBD329da53b-6f26-4590-be0d-2f20b0ab7b846
826919phentermine hydrochloride 8 MG Oral TabletSCD329da53b-6f26-4590-be0d-2f20b0ab7b846
1810304Lomaira 8 MG (equivalent to phentermine 6.4 MG) Oral TabletSY329da53b-6f26-4590-be0d-2f20b0ab7b846
1810304Lomaira 8 MG Oral TabletSY329da53b-6f26-4590-be0d-2f20b0ab7b846
826919phentermine HCl 8 MG (equivalent to phentermine 6.4 MG) Oral TabletSY329da53b-6f26-4590-be0d-2f20b0ab7b846
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 startMarketing endSampleExclude flagStatus
10702-001-031070200010330 TABLET in 1 BOTTLE (10702-001-03) 30 tablet2016-09-120000-00-00NoNoCurrent
10702-001-061070200010660 TABLET in 1 BOTTLE (10702-001-06) 60 tablet2016-09-120000-00-00NoNoCurrent
10702-001-091070200010990 TABLET in 1 BOTTLE (10702-001-09) 90 tablet2016-09-120000-00-00NoNoCurrent
10702-001-10107020001101000 TABLET in 1 BOTTLE (10702-001-10) 1000 tablet2016-09-120000-00-00NoNoCurrent
10702-001-2510702000125250 TABLET in 1 BOTTLE (10702-001-25) 250 tablet2016-09-120000-00-00NoNoCurrent
10702-001-5010702000150500 TABLET in 1 BOTTLE (10702-001-50) 500 tablet2016-09-120000-00-00NoNoCurrent