Home NDC 0713-0352 Betaine
Product NDC 0713-0352
11-digit product format 007130352
Labeler code 0713
Product ID 0713-0352_0863970c-af47-44c7-8418-65f17df50e68
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Betaine
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA214864
Marketing category ANDA
Marketing start 2023-01-01
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 42 .
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 2026-08-18 06:07:40 2026-07 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 caaa826d4ba7…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# Additional Listing Data#
Finished product Yes
Brand name base Betaine
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 0713-0352-81 Betaine 180 g in 1 BOTTLE POWDER, FOR SOLUTION 180 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0352 BETAINE POWDER, FOR SOLUTION [COSETTE PHARMACEUTICALS, INC.] 1 Current NDC, Legacy NDC, 1 package rows 20221105_99b667fa-b00c-465b-bbed-36f317078115.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 0713-0352-81 00713035281 180 g in 1 BOTTLE (0713-0352-81) 180 g 2023-01-01 0000-00-00 No No Current