THEOPHYLLINE

Orange BookUNIISPLATC R03DA04

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

Identification

ManufacturerPAI Holdings, LLC dba PAI Pharma

CountryUS (United States)

ATC codeR03DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0121482040
4 TRAY in 1 CASE (0121-4820-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4820-15)

Annotations

UNII (FDA Substance ID)

C137DTR5RG

THEOPHYLLINE

RxCUI 10438

Orange Book

A206344

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": "0121-4820_895f63e5-665b-4227-8e44-6971ba5ce294",
  "productndc": "0121-4820",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "206344",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "80MG/15ML",
        "product_no": "001",
        "approval_date": "Dec 16, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "THEOPHYLLINE",
  "proprietary_name": "THEOPHYLLINE",
  "active_ingred_unit": "mg/15mL",
  "application_number": "ANDA206344",
  "marketing_category": "ANDA",
  "nonproprietary_name": "THEOPHYLLINE",
  "start_marketing_date": "20161216",
  "active_numerator_strength": "80"
}

Related drugs

Other records sharing ATC code R03DA04.

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