Theophylline

Orange BookUNIISPLATC R03DA04

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

Identification

ManufacturerChartwell RX, LLC

CountryUS (United States)

ATC codeR03DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6213555624
2 TRAY in 1 BOX (62135-556-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (62135-556-51)
ndc11
6213555647
473 mL in 1 BOTTLE (62135-556-47)

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": "62135-556_4a2adbbe-acaa-a2bf-e063-6294a90a44c3",
  "productndc": "62135-556",
  "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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