Nateglinide

Product NDC
64380-167
11-digit product format
643800167
Labeler code
64380
Product ID
64380-167_774c246f-3d18-40d4-882f-4786d9382883
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nateglinide
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA077463
Marketing category
ANDA
Marketing start
2022-05-09
Substance
NATEGLINIDE
Active strength
60 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
NATEGLINIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii41X3PWK4O2
Rxcui311919, 314142

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
1a9c08ff-3275-8942-ea88-fa08fe78716cProduct name520190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-167-01Nateglinide100 in 1 BOTTLE, PLASTICTABLET1004
64380-167-02Nateglinide90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-167-02EA - Each64380-16717bca32e-5190-4773-8eea-3737d0368ebb12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-167NATEGLINIDE TABLET [STRIDES PHARMA SCIENCE LIMITED]4Current NDC, Legacy NDC, 2 package rows20250226_0ccf9b07-3c21-482d-abeb-a06ceb482c7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311919nateglinide 120 MG Oral TabletPSNb17ead66-dc11-4e54-9ba6-00619510f27b5
314142nateglinide 60 MG Oral TabletPSNb17ead66-dc11-4e54-9ba6-00619510f27b5
311919nateglinide 120 MG Oral TabletSCDb17ead66-dc11-4e54-9ba6-00619510f27b5
314142nateglinide 60 MG Oral TabletSCDb17ead66-dc11-4e54-9ba6-00619510f27b5
311919nateglinide 120 MG Oral TabletPSN0ccf9b07-3c21-482d-abeb-a06ceb482c7b4
314142nateglinide 60 MG Oral TabletPSN0ccf9b07-3c21-482d-abeb-a06ceb482c7b4
311919nateglinide 120 MG Oral TabletSCD0ccf9b07-3c21-482d-abeb-a06ceb482c7b4
314142nateglinide 60 MG Oral TabletSCD0ccf9b07-3c21-482d-abeb-a06ceb482c7b4
311919nateglinide 120 MG Oral TabletPSNe920b343-f53e-7487-e053-2995a90a719a2
314142nateglinide 60 MG Oral TabletPSNe920b343-f53e-7487-e053-2995a90a719a2
311919nateglinide 120 MG Oral TabletSCDe920b343-f53e-7487-e053-2995a90a719a2
314142nateglinide 60 MG Oral TabletSCDe920b343-f53e-7487-e053-2995a90a719a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-167-0164380016701100 TABLET in 1 BOTTLE, PLASTIC (64380-167-01) 100 tablet2022-05-090000-00-00NoNoCurrent
64380-167-026438001670290 TABLET in 1 BOTTLE, PLASTIC (64380-167-02) 90 tablet2022-09-070000-00-00NoNoCurrent