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United States · US · US:0641-6267_a6bcf6c4-f765-4334-9743-c5db0546d903

Caffeine Citrate

Orange BookUNIISPLATC N06BC01

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN06BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0641626710
    10 VIAL in 1 BOX (0641-6267-10) / 3 mL in 1 VIAL (0641-6267-01)

Annotations

UNII (FDA Substance ID)
U26EO4675Q
CAFFEINE CITRATE
RxCUI 20033
Orange Book
N020793
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "U26EO4675Q",
    "rxcui": "20033",
    "inchikey": "RCQXSQPPHJPGOF-UHFFFAOYSA-N",
    "display_name": "CAFFEINE CITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "6d9b3926-7198-5e00-e053-2a91aa0a9580": {
      "match": "brand_token",
      "title": "CAFFEINE TABLET [CVS PHARMACY, INC.]",
      "spl_version": "5",
      "published_date": "2026-02-26"
    }
  },
  "productid": "0641-6267_a6bcf6c4-f765-4334-9743-c5db0546d903",
  "productndc": "0641-6267",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "020793",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 30MG BASE/3ML (EQ 10MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Sep 21, 1999"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Apr 12, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CAFFEINE CITRATE",
  "proprietary_name": "Caffeine Citrate",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020793",
  "marketing_category": "NDA",
  "nonproprietary_name": "caffeine citrate",
  "start_marketing_date": "20240111",
  "active_numerator_strength": "20"
}

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