Home NDC 72647-900-01 Betaine Anhydrous for Oral Solution
Product NDC 72647-900
Requested package NDC 72647-900-01
11-digit product format 726470900
Labeler code 72647
Product ID 72647-900_acce10dd-c8fa-4457-b3ed-d716c9978e29
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Betaine Anhydrous
Dosage form FOR SOLUTION
Route ORAL
Labeler OAKRUM PHARMA, LLC
Application ANDA214864
Marketing category ANDA
Marketing start 2022-02-03
Marketing end 2024-04-30
Substance BETAINE
Active strength 1 g/g
Pharmacologic classes Methylating Activity [MoA], Methylating Agent [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A214864-001 BETAINE BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214864-001 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.
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 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Betaine BETAINE Cosette Pharmaceuticals, Inc. 99b667fa-b00c-465b-bbed-36f317078115 2026-05-20 Warnings, Adverse reactions Exact identifier application applno (ANDA): 214864 application number: ANDA214864
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72647-900-01 72647090001 180 g in 1 BOTTLE (72647-900-01) 180 g 2022-02-03 2024-04-30 No No Current