Home NDC 0172-7313 Cyclosporine
Product NDC 0172-7313
11-digit product format 001727313
Labeler code 0172
Product ID 0172-7313_94a2cdae-e60e-47c4-8bca-8baac9f21b33
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclosporine
Dosage form SOLUTION
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA065078
Marketing category ANDA
Marketing start 2005-03-29
Substance CYCLOSPORINE
Active strength 100 mg/mL
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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065078-001 CYCLOSPORINE CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065078-001 AB1
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 2 · 43 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 2026-09-14 22:38:34 2026-08 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065078-001 CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 2005-03-25 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 835886 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 0172-7313-20 Cyclosporine 1 in 1 PACKAGE SOLUTION 1 18 0172-7313-20 Cyclosporine 50 mL in 1 BOTTLE SOLUTION 50 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0172-7313 CYCLOSPORINE SOLUTION [TEVA PHARMACEUTICALS USA, INC.] 18 Current NDC, Legacy NDC, 2 package rows 20250502_f3dc2a50-1084-4190-a6f3-37034a04db86.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 Marketing end Sample Exclude flag Status 0172-7313-20 00172731320 1 BOTTLE in 1 PACKAGE (0172-7313-20) / 50 mL in 1 BOTTLE 1 bottle 2005-03-29 0000-00-00 No No Current