Theophylline

Orange BookUNIISPLATC R03DA04

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

Identification

ManufacturerChartwell Governmental & Specialty RX, LLC.

CountryUS (United States)

ATC codeR03DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6899955624
2 TRAY in 1 BOX (68999-556-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (68999-556-51)

Annotations

UNII (FDA Substance ID)

0I55128JYK

THEOPHYLLINE ANHYDROUS

RxCUI 91178

Orange Book

A091156

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "0I55128JYK",
    "rxcui": "91178",
    "inchikey": "ZFXYFBGIUFBOJW-UHFFFAOYSA-N",
    "display_name": "THEOPHYLLINE ANHYDROUS",
    "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": "68999-556_43905546-0c51-ab49-e063-6294a90a4a31",
  "productndc": "68999-556",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "091156",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "80MG/15ML",
        "product_no": "001",
        "approval_date": "Apr 13, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "THEOPHYLLINE ANHYDROUS",
  "proprietary_name": "Theophylline",
  "active_ingred_unit": "mg/15mL",
  "application_number": "ANDA091156",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Theophylline",
  "start_marketing_date": "20110413",
  "active_numerator_strength": "80"
}

Related drugs

Other records sharing ATC code R03DA04.

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