betaine

Generic: betaine

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name betaine
Generic Name betaine
Labeler cosette pharmaceuticals, inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

betaine 1 g/g

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0352
Product ID 0713-0352_99b667fa-b00c-465b-bbed-36f317078115
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214864
Listing Expiration 2026-12-31
Marketing Start 2022-11-04

Pharmacologic Class

Established (EPC)
methylating agent [epc]
Mechanism of Action
methylating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130352
Hyphenated Format 0713-0352

Supplemental Identifiers

RxCUI
562847
UPC
0307130352819
UNII
3SCV180C9W
NUI
N0000175804 N0000175805

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name betaine (source: ndc)
Generic Name betaine (source: ndc)
Application Number ANDA214864 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/g
source: ndc
Packaging
  • 180 g in 1 BOTTLE (0713-0352-81)
source: ndc

Packages (1)

0713-0352-81 180 g in 1 BOTTLE (0713-0352-81)

Ingredients (1)

betaine (1 g/g)

Linked Drug Pages (1)

Betaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "99b667fa-b00c-465b-bbed-36f317078115", "openfda": {"nui": ["N0000175804", "N0000175805"], "upc": ["0307130352819"], "unii": ["3SCV180C9W"], "rxcui": ["562847"], "spl_set_id": ["99b667fa-b00c-465b-bbed-36f317078115"], "pharm_class_epc": ["Methylating Agent [EPC]"], "pharm_class_moa": ["Methylating Activity [MoA]"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 g in 1 BOTTLE (0713-0352-81)", "package_ndc": "0713-0352-81", "marketing_start_date": "20221104"}], "brand_name": "Betaine", "product_id": "0713-0352_99b667fa-b00c-465b-bbed-36f317078115", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Methylating Activity [MoA]", "Methylating Agent [EPC]"], "product_ndc": "0713-0352", "generic_name": "Betaine", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Betaine", "active_ingredients": [{"name": "BETAINE", "strength": "1 g/g"}], "application_number": "ANDA214864", "marketing_category": "ANDA", "marketing_start_date": "20221104", "listing_expiration_date": "20261231"}