Home NDC 0074-3109 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065003-001 GENGRAF CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-05-12 A065003-002 GENGRAF CYCLOSPORINE 50MG CAPSULE / ORAL 2000-05-12 A065003-003 GENGRAF CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-05-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A065003-001 GENGRAF 25MG CAPSULE / ORAL AB1 2000-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065003-002 GENGRAF 50MG CAPSULE / ORAL 2000-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065003-003 GENGRAF 100MG CAPSULE / ORAL AB1 2000-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065003-001 GENGRAF 25MG CAPSULE / ORAL AB1 2000-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065003-002 GENGRAF 50MG CAPSULE / ORAL 2000-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065003-003 GENGRAF 100MG CAPSULE / ORAL AB1 2000-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065003-001 GENGRAF 25MG CAPSULE / ORAL AB1 2000-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065003-002 GENGRAF 50MG CAPSULE / ORAL 2000-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065003-003 GENGRAF 100MG CAPSULE / ORAL AB1 2000-05-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065003-001 GENGRAF 25MG CAPSULE / ORAL AB1 2000-05-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065003-002 GENGRAF 50MG CAPSULE / ORAL 2000-05-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065003-003 GENGRAF 100MG CAPSULE / ORAL AB1 2000-05-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065003-001 GENGRAF 25MG CAPSULE / ORAL AB1 2000-05-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065003-002 GENGRAF 50MG CAPSULE / ORAL 2000-05-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065003-003 GENGRAF 100MG CAPSULE / ORAL AB1 2000-05-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065003-001 GENGRAF 25MG CAPSULE / ORAL AB1 2000-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065003-002 GENGRAF 50MG CAPSULE / ORAL 2000-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065003-003 GENGRAF 100MG CAPSULE / ORAL AB1 2000-05-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065003-001 GENGRAF 25MG CAPSULE / ORAL AB1 2000-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065003-002 GENGRAF 50MG CAPSULE / ORAL 2000-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065003-003 GENGRAF 100MG CAPSULE / ORAL AB1 2000-05-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065003-001 GENGRAF 25MG CAPSULE / ORAL AB1 2000-05-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065003-002 GENGRAF 50MG CAPSULE / ORAL 2000-05-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065003-003 GENGRAF 100MG CAPSULE / ORAL AB1 2000-05-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065003-001 GENGRAF 25MG CAPSULE / ORAL AB1 2000-05-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065003-002 GENGRAF 50MG CAPSULE / ORAL 2000-05-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065003-003 GENGRAF 100MG CAPSULE / ORAL AB1 2000-05-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065003-001 GENGRAF 25MG CAPSULE / ORAL AB1 2000-05-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065003-002 GENGRAF 50MG CAPSULE / ORAL 2000-05-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065003-003 GENGRAF 100MG CAPSULE / ORAL AB1 2000-05-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065003-001 GENGRAF 25MG CAPSULE / ORAL AB1 2000-05-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065003-002 GENGRAF 50MG CAPSULE / ORAL 2000-05-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065003-003 GENGRAF 100MG CAPSULE / ORAL AB1 2000-05-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065003-001 GENGRAF 25MG CAPSULE / ORAL AB1 2000-05-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065003-002 GENGRAF 50MG CAPSULE / ORAL 2000-05-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065003-003 GENGRAF 100MG CAPSULE / ORAL AB1 2000-05-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065003-001 GENGRAF 25MG CAPSULE / ORAL AB1 2000-05-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065003-002 GENGRAF 50MG CAPSULE / ORAL 2000-05-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065003-003 GENGRAF 100MG CAPSULE / ORAL AB1 2000-05-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065003-001 GENGRAF 25MG CAPSULE / ORAL AB1 2000-05-12 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Gengraf
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOSPORINE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 83HN0GTJ6D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 241834 Internal RxNorm lookup 835835 Internal RxNorm lookup 835894 Internal RxNorm lookup 835896 Internal RxNorm lookup 835925 Internal RxNorm lookup 1797521 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0074-3109-32 Gengraf 5 in 1 CARTON CAPSULE 5 1256 0074-3109-32 Gengraf 6 in 1 BLISTER PACK CAPSULE 6 1256
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0074-3109 GENGRAF (CYCLOSPORINE) CAPSULE [ABBVIE INC.] 1254 Current NDC, Legacy NDC, 2 package rows 20240822_e896cbfe-4745-4088-82a3-8dc10b75c41f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 241834 cycloSPORINE, modified 100 MG Oral Capsule PSN e896cbfe-4745-4088-82a3-8dc10b75c41f 1256 835894 cycloSPORINE, modified 25 MG Oral Capsule PSN e896cbfe-4745-4088-82a3-8dc10b75c41f 1256 835925 cycloSPORINE, modified 50 MG Oral Capsule PSN e896cbfe-4745-4088-82a3-8dc10b75c41f 1256 835835 GENGRAF 100 MG Oral Capsule PSN e896cbfe-4745-4088-82a3-8dc10b75c41f 1256 835896 GENGRAF 25 MG Oral Capsule PSN e896cbfe-4745-4088-82a3-8dc10b75c41f 1256 1797521 GENGRAF 50 MG Oral Capsule PSN e896cbfe-4745-4088-82a3-8dc10b75c41f 1256 835835 cyclosporine, modified 100 MG Oral Capsule [Gengraf] SBD e896cbfe-4745-4088-82a3-8dc10b75c41f 1256 835896 cyclosporine, modified 25 MG Oral Capsule [Gengraf] SBD e896cbfe-4745-4088-82a3-8dc10b75c41f 1256 1797521 cyclosporine, modified 50 MG Oral Capsule [Gengraf] SBD e896cbfe-4745-4088-82a3-8dc10b75c41f 1256 241834 cyclosporine, modified 100 MG Oral Capsule SCD e896cbfe-4745-4088-82a3-8dc10b75c41f 1256 835894 cyclosporine, modified 25 MG Oral Capsule SCD e896cbfe-4745-4088-82a3-8dc10b75c41f 1256 835925 cyclosporine, modified 50 MG Oral Capsule SCD e896cbfe-4745-4088-82a3-8dc10b75c41f 1256 835835 Gengraf 100 MG Oral Capsule SY e896cbfe-4745-4088-82a3-8dc10b75c41f 1256 835896 Gengraf 25 MG Oral Capsule SY e896cbfe-4745-4088-82a3-8dc10b75c41f 1256 1797521 Gengraf 50 MG Oral Capsule SY e896cbfe-4745-4088-82a3-8dc10b75c41f 1256
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0074-3109-32 00074310932 5 BLISTER PACK in 1 CARTON (0074-3109-32) / 6 CAPSULE in 1 BLISTER PACK 5 blister pack 2015-11-01 0000-00-00 No No Current