Home NDC 52276-400 Cystadane
Product NDC 52276-400
11-digit product format 522760400
Labeler code 52276
Product ID 52276-400_3a4fdd66-b72b-4aa3-94bb-bac8af98b150
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name betaine
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Recordati Rare Diseases
Application NDA020576
Marketing category NDA
Marketing start 1996-10-25
Substance BETAINE
Active strength 1 g/g
Pharmacologic classes Methylating Activity [MoA], Methylating Agent [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020576-001 CYSTADANE BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020576-001 AB
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 · 41 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 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 1996-10-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 1996-10-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 1996-10-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 1996-10-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 1996-10-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 1996-10-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 1996-10-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 1996-10-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Cystadane
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BETAINE 1 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3SCV180C9W Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 404539 Internal RxNorm lookup 562847 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 52276-400-01 Cystadane 180 g in 1 BOTTLE POWDER, FOR SOLUTION 180 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52276-400 CYSTADANE (BETAINE) POWDER, FOR SOLUTION [RECORDATI RARE DISEASES] 5 Current NDC, Legacy NDC, 1 package rows 20230112_31a684d0-cd98-4e46-b43a-ccbd17c41559.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 52276-400-01 52276040001 180 g in 1 BOTTLE (52276-400-01) 180 g 2017-04-13 0000-00-00 No No Current