Home NDC 75907-048 Cyclosporine
Product NDC 75907-048
11-digit product format 759070048
Labeler code 75907
Product ID 75907-048_d94fae26-e557-7f8f-1755-846c8f091506
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclosporine
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Dr. Reddy's Laboratories Inc
Application ANDA065044
Marketing category ANDA
Marketing start 2024-07-01
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 2026-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065044-001 CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 A065044-002 CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20
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 3 · 82 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 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 782e0a99824c…
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 Cyclosporine
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 241834 Internal RxNorm lookup 835894 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 75907-048-30 Cyclosporine 30 in 1 BOX CAPSULE, LIQUID FILLED 30 1 75907-048-81 Cyclosporine 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75907-048 CYCLOSPORINE CAPSULE, LIQUID FILLED [DR. REDDY'S LABORATORIES INC] 1 Current NDC, 2 package rows 20240701_64ec430a-e930-145c-e766-13fb49b64644.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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 75907-048-30 75907004830 30 BLISTER PACK in 1 BOX (75907-048-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (75907-048-81) 30 blister pack 2024-07-01 No No Current 75907-048-81 75907004881 1 in 1 BLISTER PACK Historical