Home NDC 71863-115 Betaine Anhydrous
Product NDC 71863-115
11-digit product format 718630115
Labeler code 71863
Product ID 71863-115_42c7a42b-6a75-69d3-e063-6294a90acc18
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Betaine Anhydrous
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Eton Pharmaceuticals, Inc.
Application ANDA210508
Marketing category ANDA
Marketing start 2022-01-28
Substance BETAINE
Active strength 1 g/g
Pharmacologic classes Methylating Activity [MoA], Methylating Agent [EPC]
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 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 A210508-001 BETAINE BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210508-001 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 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210508-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2022-01-28 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Betaine Anhydrous
Listing expiration 2026-12-31 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 71863-115-18 Betaine Anhydrous 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 71863-115 BETAINE ANHYDROUS POWDER, FOR SOLUTION [ETON PHARMACEUTICALS, INC.] 6 Current NDC, 1 package rows 20241025_ee8a95c3-df9f-6e55-e053-2a95a90ab17b.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 Sample Exclude flag Status 71863-115-18 71863011518 180 g in 1 BOTTLE (71863-115-18) 180 g 2022-01-28 No No Current