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United States · US · US:63629-8610_00b2a93c-92de-90c6-e063-6294a90a6d33

Ammonium Lactate

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6362986101
    225 g in 1 BOTTLE, PLASTIC (63629-8610-1)

Annotations

UNII (FDA Substance ID)
67M901L9NQ
AMMONIUM LACTATE
RxCUI 215247
Orange Book
A075570
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "67M901L9NQ",
    "rxcui": "215247",
    "inchikey": "RZOBLYBZQXQGFY-UHFFFAOYSA-N",
    "display_name": "AMMONIUM LACTATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "030e8bd1-0ff3-479f-aa77-16fab701a111": {
      "match": "brand_token",
      "title": "AMMONIUM LACTATE CREAM [REMEDYREPACK INC.]",
      "spl_version": "5",
      "published_date": "2026-04-15"
    }
  },
  "productid": "63629-8610_00b2a93c-92de-90c6-e063-6294a90a6d33",
  "productndc": "63629-8610",
  "dosage_form": "LOTION",
  "orange_book": {
    "appl_no": "075570",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12% BASE",
        "product_no": "001",
        "approval_date": "Jun 23, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMMONIUM LACTATE",
  "proprietary_name": "Ammonium Lactate",
  "active_ingred_unit": "g/100g",
  "application_number": "ANDA075570",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ammonium Lactate",
  "start_marketing_date": "20060620",
  "active_numerator_strength": "12"
}

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