ammonium lactate

Generic: ammonium lactate

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ammonium lactate
Generic Name ammonium lactate
Labeler padagis israel pharmaceuticals ltd
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

ammonium lactate 12 g/100g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-493
Product ID 45802-493_5282be09-db4d-42df-bae7-5284aad8f2a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075774
Listing Expiration 2026-12-31
Marketing Start 2006-08-16

Pharmacologic Class

Established (EPC)
alpha-hydroxy acid [epc]
Chemical Structure
hydroxy acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802493
Hyphenated Format 45802-493

Supplemental Identifiers

RxCUI
543460
UNII
67M901L9NQ
NUI
N0000175842 M0010745

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 ammonium lactate (source: ndc)
Generic Name ammonium lactate (source: ndc)
Application Number ANDA075774 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 12 g/100g
source: ndc
Packaging
  • 385 g in 1 BOTTLE, PUMP (45802-493-26)
source: ndc

Packages (1)

45802-493-26 385 g in 1 BOTTLE, PUMP (45802-493-26)

Ingredients (1)

ammonium lactate (12 g/100g)

Linked Drug Pages (1)

Ammonium Lactate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "5282be09-db4d-42df-bae7-5284aad8f2a5", "openfda": {"nui": ["N0000175842", "M0010745"], "unii": ["67M901L9NQ"], "rxcui": ["543460"], "spl_set_id": ["7096d38e-2bd1-4374-9bf6-7fd09ef7509c"], "pharm_class_cs": ["Hydroxy Acids [CS]"], "pharm_class_epc": ["alpha-Hydroxy Acid [EPC]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "385 g in 1 BOTTLE, PUMP (45802-493-26)", "package_ndc": "45802-493-26", "marketing_start_date": "20070219"}], "brand_name": "Ammonium Lactate", "product_id": "45802-493_5282be09-db4d-42df-bae7-5284aad8f2a5", "dosage_form": "CREAM", "pharm_class": ["Acidifying Activity [MoA]"], "product_ndc": "45802-493", "generic_name": "Ammonium Lactate", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ammonium Lactate", "active_ingredients": [{"name": "AMMONIUM LACTATE", "strength": "12 g/100g"}], "application_number": "ANDA075774", "marketing_category": "ANDA", "marketing_start_date": "20060816", "listing_expiration_date": "20261231"}