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 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 2026-08-01 22:54:32 2026-06 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A214864-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
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