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United States · US · US:0121-0820_895f63e5-665b-4227-8e44-6971ba5ce294

THEOPHYLLINE

Orange BookUNIISPLATC R03DA04

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

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 · 2

  • ndc11
    0121082004
    118 mL in 1 BOTTLE (0121-0820-04)
  • ndc11
    0121082016
    473 mL in 1 BOTTLE (0121-0820-16)

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": "0121-0820_895f63e5-665b-4227-8e44-6971ba5ce294",
  "productndc": "0121-0820",
  "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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