Tacrolimus

Product NDC
70377-014
11-digit product format
703770014
Labeler code
70377
Product ID
70377-014_640e066c-f2a3-5fb2-4b55-4ac9aec0d31b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
Biocon Pharma Inc.
Application
ANDA212297
Marketing category
ANDA
Marketing start
2020-12-23
Substance
TACROLIMUS
Active strength
.5 mg/1
Pharmacologic classes
Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tacrolimus
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TACROLIMUS.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWM0HAQ4WNM

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
df369ad4-19d8-393a-de46-8c6255b8b360Product name820251120
d2a74186-7b26-dbcc-9435-50b3d0be14abProduct name220250114
a64835ae-fa9d-41d8-9a93-36828ba72b96Product name320190611
b4a869e4-9fcd-47bd-95e3-85e7c75f8badProduct name120150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70377-014-11Tacrolimus100 in 1 BOTTLECAPSULE10012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-014TACROLIMUS (TACROLIMUS) CAPSULE [BIOCON PHARMA INC.]8Current NDC, Legacy NDC, 1 package rows20211014_0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313190tacrolimus 0.5 MG Oral CapsulePSN0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60f12
198377tacrolimus 1 MG Oral CapsulePSN0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60f12
198378tacrolimus 5 MG Oral CapsulePSN0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60f12
313190tacrolimus 0.5 MG Oral CapsuleSCD0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60f12
198377tacrolimus 1 MG Oral CapsuleSCD0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60f12
198378tacrolimus 5 MG Oral CapsuleSCD0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60f12
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSY0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60f12
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60f12
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70377-014-1170377001411100 CAPSULE in 1 BOTTLE (70377-014-11) 100 capsule2020-12-230000-00-00NoNoCurrent