Home NDC 64811-400 Cystadane
Product NDC 64811-400
11-digit product format 648110400
Labeler code 64811
Product ID 64811-400_7c254f3d-2a1c-3b17-e053-2a91aa0aea34
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BETAINE
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Ropack Inc.
Application NDA020576
Marketing category NDA
Marketing start 2017-04-13
Marketing end 0000-00-00
Substance BETAINE
Active strength 1 g/g
Pharmacologic classes Methylating Activity [MoA],Methylating Agent [EPC]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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# 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.