FDA.reportPublic FDA data

Gengraf

Product NDC
0074-3109
11-digit product format
000743109
Labeler code
0074
Product ID
0074-3109_38f517b9-c5d1-479a-9117-f65ea1d479d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclosporine
Dosage form
CAPSULE
Route
ORAL
Labeler
AbbVie Inc.
Application
ANDA065003
Marketing category
ANDA
Marketing start
2015-11-01
Substance
CYCLOSPORINE
Active strength
100 mg/1
Pharmacologic classes
Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein 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
Gengraf
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOSPORINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83HN0GTJ6D
Rxcui241834, 835835, 835894, 835896, 835925, 1797521

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1be408a0-e15a-4092-b35e-4e294e65196fProduct name320240216
b3fdee3e-0c46-442f-aad5-aa71941d5621Product name120231023
78fb0708-fce5-decd-6611-5a9fbe3e3decProduct name320230327
54840517-000d-4fcb-b976-a6ddd102faa0Product name120220120
a5ba3bd0-8411-4005-ac3b-a41d8ee0633aProduct name120181029
b1c0d609-8b97-06ee-2cd0-5652a4b1d019Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-3109-32Gengraf5 in 1 CARTONCAPSULE51256
0074-3109-32Gengraf6 in 1 BLISTER PACKCAPSULE61256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-3109-32EA - Each0074-31092f2f1d38-ee36-42e9-9d65-92f4407e16f012016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOSPORINEACTIVE INGREDIENT83HN0GTJ6DGENGRAF (CYCLOSPORINE) CAPSULE [ABBVIE INC.]1209
CYCLOSPORINEACTIVE MOIETY83HN0GTJ6DGENGRAF (CYCLOSPORINE) CAPSULE [ABBVIE INC.]1209
ALCOHOLINACTIVE INGREDIENT3K9958V90MGENGRAF (CYCLOSPORINE) CAPSULE [ABBVIE INC.]1209
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGENGRAF (CYCLOSPORINE) CAPSULE [ABBVIE INC.]1209
GELATININACTIVE INGREDIENT2G86QN327LGENGRAF (CYCLOSPORINE) CAPSULE [ABBVIE INC.]1209
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGENGRAF (CYCLOSPORINE) CAPSULE [ABBVIE INC.]1209
POLYOXYL 35 CASTOR OILINACTIVE INGREDIENT6D4M1DAL6OGENGRAF (CYCLOSPORINE) CAPSULE [ABBVIE INC.]1209
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGENGRAF (CYCLOSPORINE) CAPSULE [ABBVIE INC.]1209
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GENGRAF (CYCLOSPORINE) CAPSULE [ABBVIE INC.]1209
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56GENGRAF (CYCLOSPORINE) CAPSULE [ABBVIE INC.]1209
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGENGRAF (CYCLOSPORINE) CAPSULE [ABBVIE INC.]1209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-3109GENGRAF (CYCLOSPORINE) CAPSULE [ABBVIE INC.]1254Current NDC, Legacy NDC, 2 package rows20240822_e896cbfe-4745-4088-82a3-8dc10b75c41f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
241834cycloSPORINE, modified 100 MG Oral CapsulePSNe896cbfe-4745-4088-82a3-8dc10b75c41f1256
835894cycloSPORINE, modified 25 MG Oral CapsulePSNe896cbfe-4745-4088-82a3-8dc10b75c41f1256
835925cycloSPORINE, modified 50 MG Oral CapsulePSNe896cbfe-4745-4088-82a3-8dc10b75c41f1256
835835GENGRAF 100 MG Oral CapsulePSNe896cbfe-4745-4088-82a3-8dc10b75c41f1256
835896GENGRAF 25 MG Oral CapsulePSNe896cbfe-4745-4088-82a3-8dc10b75c41f1256
1797521GENGRAF 50 MG Oral CapsulePSNe896cbfe-4745-4088-82a3-8dc10b75c41f1256
835835cyclosporine, modified 100 MG Oral Capsule [Gengraf]SBDe896cbfe-4745-4088-82a3-8dc10b75c41f1256
835896cyclosporine, modified 25 MG Oral Capsule [Gengraf]SBDe896cbfe-4745-4088-82a3-8dc10b75c41f1256
1797521cyclosporine, modified 50 MG Oral Capsule [Gengraf]SBDe896cbfe-4745-4088-82a3-8dc10b75c41f1256
241834cyclosporine, modified 100 MG Oral CapsuleSCDe896cbfe-4745-4088-82a3-8dc10b75c41f1256
835894cyclosporine, modified 25 MG Oral CapsuleSCDe896cbfe-4745-4088-82a3-8dc10b75c41f1256
835925cyclosporine, modified 50 MG Oral CapsuleSCDe896cbfe-4745-4088-82a3-8dc10b75c41f1256
835835Gengraf 100 MG Oral CapsuleSYe896cbfe-4745-4088-82a3-8dc10b75c41f1256
835896Gengraf 25 MG Oral CapsuleSYe896cbfe-4745-4088-82a3-8dc10b75c41f1256
1797521Gengraf 50 MG Oral CapsuleSYe896cbfe-4745-4088-82a3-8dc10b75c41f1256

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-3109-32000743109325 BLISTER PACK in 1 CARTON (0074-3109-32) / 6 CAPSULE in 1 BLISTER PACK5 blister pack2015-11-010000-00-00NoNoCurrent