THEOPHYLLINE

Orange BookUNIISPLATC R03DA04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerLeading Pharma, LLC

CountryUS (United States)

ATC codeR03DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6931522701
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-227-01)

Annotations

UNII (FDA Substance ID)

C137DTR5RG

THEOPHYLLINE

RxCUI 10438

Orange Book

A214950

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "C137DTR5RG",
    "rxcui": "10438",
    "inchikey": "INQSMEFCAIHTJG-UHFFFAOYSA-N",
    "display_name": "THEOPHYLLINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "aa80b9f4-8a5d-3e14-e053-2a95a90a8aab": {
      "match": "brand_token",
      "title": "THEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "5",
      "published_date": "2026-06-01"
    }
  },
  "productid": "69315-227_a7dacdee-6f6b-4b85-b051-7779258a6971",
  "productndc": "69315-227",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "214950",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "001",
        "approval_date": "Jan 30, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "450MG",
        "product_no": "002",
        "approval_date": "Jan 30, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "THEOPHYLLINE",
  "proprietary_name": "THEOPHYLLINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214950",
  "marketing_category": "ANDA",
  "nonproprietary_name": "THEOPHYLLINE",
  "start_marketing_date": "20230515",
  "active_numerator_strength": "450"
}

Related drugs

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