NATEGLINIDE

Product NDC
16571-759
11-digit product format
165710759
Labeler code
16571
Product ID
16571-759_9ed1dbe4-49df-4d94-9e8b-3cdc081a3dd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NATEGLINIDE
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA205544
Marketing category
ANDA
Marketing start
2020-12-16
Substance
NATEGLINIDE
Active strength
120 mg/1
Pharmacologic classes
Glinide [EPC], Potassium Channel Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NATEGLINIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NATEGLINIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii41X3PWK4O2
Rxcui311919, 314142

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1a9c08ff-3275-8942-ea88-fa08fe78716cProduct name520190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-759-01NATEGLINIDE100 in 1 BOTTLETABLET1003
16571-759-09NATEGLINIDE90 in 1 BOTTLETABLET903
16571-759-50NATEGLINIDE500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-759-09EA - Each16571-759627528c8-bda7-4292-8a0c-8643d526a3fe12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-759NATEGLINIDE TABLET [RISING PHARMA HOLDINGS, INC.]3Current NDC, Legacy NDC, 3 package rows20241211_b41f4180-96a7-411d-b827-5021e534f556.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311919nateglinide 120 MG Oral TabletPSNb41f4180-96a7-411d-b827-5021e534f5563
314142nateglinide 60 MG Oral TabletPSNb41f4180-96a7-411d-b827-5021e534f5563
311919nateglinide 120 MG Oral TabletSCDb41f4180-96a7-411d-b827-5021e534f5563
314142nateglinide 60 MG Oral TabletSCDb41f4180-96a7-411d-b827-5021e534f5563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-759-0116571075901100 TABLET in 1 BOTTLE (16571-759-01) 100 tablet2020-12-160000-00-00NoNoCurrent
16571-759-091657107590990 TABLET in 1 BOTTLE (16571-759-09) 90 tablet2020-12-160000-00-00NoNoCurrent
16571-759-5016571075950500 TABLET in 1 BOTTLE (16571-759-50) 500 tablet2020-12-160000-00-00NoNoCurrent