FDA.reportPublic FDA data

Nateglinide

Product NDC
70771-1016
11-digit product format
707711016
Labeler code
70771
Product ID
70771-1016_58be95eb-5701-463e-b80c-eb9b6c2a789d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nateglinide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA205248
Marketing category
ANDA
Marketing start
2016-10-27
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
70771-1016-0Nateglinide1000 in 1 BOTTLETABLET, FILM COATED10009
70771-1016-1Nateglinide100 in 1 BOTTLETABLET, FILM COATED1009
70771-1016-2Nateglinide10 in 1 BLISTER PACKTABLET, FILM COATED109
70771-1016-3Nateglinide30 in 1 BOTTLETABLET, FILM COATED309
70771-1016-4Nateglinide10 in 1 CARTONTABLET, FILM COATED109
70771-1016-5Nateglinide500 in 1 BOTTLETABLET, FILM COATED5009
70771-1016-9Nateglinide90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1016NATEGLINIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]9Current NDC, Legacy NDC, 7 package rows20241206_a82817dd-f8c4-4172-ba86-63c2beef456a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311919nateglinide 120 MG Oral TabletPSNa82817dd-f8c4-4172-ba86-63c2beef456a9
314142nateglinide 60 MG Oral TabletPSNa82817dd-f8c4-4172-ba86-63c2beef456a9
311919nateglinide 120 MG Oral TabletSCDa82817dd-f8c4-4172-ba86-63c2beef456a9
314142nateglinide 60 MG Oral TabletSCDa82817dd-f8c4-4172-ba86-63c2beef456a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1016-0707711016001000 TABLET, FILM COATED in 1 BOTTLE (70771-1016-0) 2016-10-270000-00-00NoNoCurrent
70771-1016-170771101601100 TABLET, FILM COATED in 1 BOTTLE (70771-1016-1) 2016-10-270000-00-00NoNoCurrent
70771-1016-27077110160210 in 1 BLISTER PACKHistorical
70771-1016-37077110160330 TABLET, FILM COATED in 1 BOTTLE (70771-1016-3) 2016-10-270000-00-00NoNoCurrent
70771-1016-47077110160410 BLISTER PACK in 1 CARTON (70771-1016-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1016-2) 10 blister pack2016-10-270000-00-00NoNoCurrent
70771-1016-570771101605500 TABLET, FILM COATED in 1 BOTTLE (70771-1016-5) 2016-10-270000-00-00NoNoCurrent
70771-1016-97077110160990 TABLET, FILM COATED in 1 BOTTLE (70771-1016-9) 2016-10-270000-00-00NoNoCurrent