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United States · US · US:53746-361_299a16c1-9627-45e2-a30c-e0f07ae9399a

Folic Acid

Orange BookUNIISPLATC V04CX02

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeV04CX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5374636101
    100 TABLET in 1 BOTTLE (53746-361-01)
  • ndc11
    5374636110
    1000 TABLET in 1 BOTTLE (53746-361-10)

Annotations

UNII (FDA Substance ID)
935E97BOY8
FOLIC ACID
RxCUI 4511
Orange Book
A040625
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "935E97BOY8",
    "rxcui": "4511",
    "inchikey": "OVBPIULPVIDEAO-LBPRGKRZSA-N",
    "display_name": "FOLIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "624469a1-ded9-453a-973e-c5a2f0602bb0": {
      "match": "brand_token",
      "title": "FOLIC ACID TABLET [CARDINAL HEALTH 107, LLC]",
      "spl_version": "5",
      "published_date": "2026-05-25"
    }
  },
  "productid": "53746-361_299a16c1-9627-45e2-a30c-e0f07ae9399a",
  "productndc": "53746-361",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040625",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Jul 21, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FOLIC ACID",
  "proprietary_name": "Folic Acid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040625",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Folic Acid",
  "start_marketing_date": "20220307",
  "active_numerator_strength": "1"
}

Related drugs

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