ammonium lactate

Generic: ammonium lactate

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ammonium lactate
Generic Name ammonium lactate
Labeler remedyrepack inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

ammonium lactate 120 mg/g

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3619
Product ID 70518-3619_3ac6df60-03d1-5d94-e063-6294a90ac618
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075883
Listing Expiration 2026-12-31
Marketing Start 2023-01-20

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 705183619
Hyphenated Format 70518-3619

Supplemental Identifiers

RxCUI
543460
UNII
67M901L9NQ
NUI
N0000175842 M0010745

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 ANDA075883 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/g
source: ndc
Packaging
  • 2 TUBE in 1 CARTON (70518-3619-0) / 140 g in 1 TUBE
source: ndc

Packages (1)

70518-3619-0 2 TUBE in 1 CARTON (70518-3619-0) / 140 g in 1 TUBE

Ingredients (1)

ammonium lactate (120 mg/g)

Linked Drug Pages (1)

Ammonium Lactate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3ac6df60-03d1-5d94-e063-6294a90ac618", "openfda": {"nui": ["N0000175842", "M0010745"], "unii": ["67M901L9NQ"], "rxcui": ["543460"], "spl_set_id": ["030e8bd1-0ff3-479f-aa77-16fab701a111"], "pharm_class_cs": ["Hydroxy Acids [CS]"], "pharm_class_epc": ["alpha-Hydroxy Acid [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "2 TUBE in 1 CARTON (70518-3619-0)  / 140 g in 1 TUBE", "package_ndc": "70518-3619-0", "marketing_start_date": "20230120"}], "brand_name": "Ammonium Lactate", "product_id": "70518-3619_3ac6df60-03d1-5d94-e063-6294a90ac618", "dosage_form": "CREAM", "pharm_class": ["Acidifying Activity [MoA]"], "product_ndc": "70518-3619", "generic_name": "Ammonium Lactate", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ammonium Lactate", "active_ingredients": [{"name": "AMMONIUM LACTATE", "strength": "120 mg/g"}], "application_number": "ANDA075883", "marketing_category": "ANDA", "marketing_start_date": "20230120", "listing_expiration_date": "20261231"}