ammonium lactate

Generic: ammonium lactate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ammonium lactate
Generic Name ammonium lactate
Labeler sun pharmaceutical industries, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

ammonium lactate 120 mg/g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1301
Product ID 51672-1301_38e5b035-6ea3-605e-e063-6294a90a7087
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075883
Listing Expiration 2026-12-31
Marketing Start 2003-04-10

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 516721301
Hyphenated Format 51672-1301

Supplemental Identifiers

RxCUI
543460
UPC
0351672130145
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 ANDA075883 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/g
source: ndc
Packaging
  • 385 g in 1 BOTTLE, PLASTIC (51672-1301-0)
  • 1 TUBE in 1 CARTON (51672-1301-2) / 140 g in 1 TUBE
  • 2 TUBE in 1 CARTON (51672-1301-4) / 140 g in 1 TUBE
source: ndc

Packages (3)

51672-1301-0 385 g in 1 BOTTLE, PLASTIC (51672-1301-0) 51672-1301-2 1 TUBE in 1 CARTON (51672-1301-2) / 140 g in 1 TUBE 51672-1301-4 2 TUBE in 1 CARTON (51672-1301-4) / 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": "38e5b035-6ea3-605e-e063-6294a90a7087", "openfda": {"nui": ["N0000175842", "M0010745"], "upc": ["0351672130145"], "unii": ["67M901L9NQ"], "rxcui": ["543460"], "spl_set_id": ["9745b6ce-f532-4e80-b6e9-477ab9db4e30"], "pharm_class_cs": ["Hydroxy Acids [CS]"], "pharm_class_epc": ["alpha-Hydroxy Acid [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "385 g in 1 BOTTLE, PLASTIC (51672-1301-0)", "package_ndc": "51672-1301-0", "marketing_start_date": "20030410"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-1301-2)  / 140 g in 1 TUBE", "package_ndc": "51672-1301-2", "marketing_start_date": "20240701"}, {"sample": false, "description": "2 TUBE in 1 CARTON (51672-1301-4)  / 140 g in 1 TUBE", "package_ndc": "51672-1301-4", "marketing_start_date": "20030410"}], "brand_name": "Ammonium Lactate", "product_id": "51672-1301_38e5b035-6ea3-605e-e063-6294a90a7087", "dosage_form": "CREAM", "pharm_class": ["Acidifying Activity [MoA]"], "product_ndc": "51672-1301", "generic_name": "Ammonium Lactate", "labeler_name": "Sun Pharmaceutical Industries, 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": "20030410", "listing_expiration_date": "20261231"}