Home NDC 0378-9045 Cystagon
Product NDC 0378-9045
11-digit product format 003789045
Labeler code 0378
Product ID 0378-9045_29dfd298-96ed-4a5f-a573-b24f5ffa618b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cysteamine bitartrate
Dosage form CAPSULE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA020392
Marketing category NDA
Marketing start 2005-04-11
Substance CYSTEAMINE BITARTRATE
Active strength 150 mg/1
Pharmacologic classes Cystine Depleting Agent [EPC], Cystine Disulfide Reduction [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 42 .
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 N020392-001 CYSTAGON CYSTEAMINE BITARTRATE EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 N020392-002 CYSTAGON CYSTEAMINE BITARTRATE EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15
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 · 84 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 2026-08-18 06:07:40 2026-07 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base Cystagon
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYSTEAMINE BITARTRATE 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QO84GZ3TST Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 209788 Internal RxNorm lookup 209789 Internal RxNorm lookup 309636 Internal RxNorm lookup 309637 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 0378-9045-05 Cystagon 500 in 1 BOTTLE, PLASTIC CAPSULE 500 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-9045 CYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.] 13 Current NDC, Legacy NDC, 1 package rows 20241215_f495b76d-96c6-48e5-8fa3-30a4336628eb.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 0378-9045-05 00378904505 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05) 500 capsule 2005-04-11 2030-01-01 No No Current