betaine anhydrous

Generic: betaine anhydrous

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

Drug Facts

Product Profile

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

betaine 1 g/g

Manufacturer
Eton Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 71863-115
Product ID 71863-115_42c7a42b-6a75-69d3-e063-6294a90acc18
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210508
Listing Expiration 2026-12-31
Marketing Start 2022-01-28

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 71863115
Hyphenated Format 71863-115

Supplemental Identifiers

RxCUI
562847
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 anhydrous (source: ndc)
Generic Name betaine anhydrous (source: ndc)
Application Number ANDA210508 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/g
source: ndc
Packaging
  • 180 g in 1 BOTTLE (71863-115-18)
source: ndc

Packages (1)

71863-115-18 180 g in 1 BOTTLE (71863-115-18)

Ingredients (1)

betaine (1 g/g)

Linked Drug Pages (1)

Betaine Anhydrous ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "42c7a42b-6a75-69d3-e063-6294a90acc18", "openfda": {"nui": ["N0000175804", "N0000175805"], "unii": ["3SCV180C9W"], "rxcui": ["562847"], "spl_set_id": ["ee8a95c3-df9f-6e55-e053-2a95a90ab17b"], "pharm_class_epc": ["Methylating Agent [EPC]"], "pharm_class_moa": ["Methylating Activity [MoA]"], "manufacturer_name": ["Eton Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 g in 1 BOTTLE (71863-115-18)", "package_ndc": "71863-115-18", "marketing_start_date": "20220128"}], "brand_name": "Betaine Anhydrous", "product_id": "71863-115_42c7a42b-6a75-69d3-e063-6294a90acc18", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Methylating Activity [MoA]", "Methylating Agent [EPC]"], "product_ndc": "71863-115", "generic_name": "Betaine Anhydrous", "labeler_name": "Eton Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Betaine Anhydrous", "active_ingredients": [{"name": "BETAINE", "strength": "1 g/g"}], "application_number": "ANDA210508", "marketing_category": "ANDA", "marketing_start_date": "20220128", "listing_expiration_date": "20261231"}