Theophylline

Orange BookUNIISPLATC R03DA04

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC codeR03DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6846238001
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-380-01)
ndc11
6846238005
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-380-05)

Annotations

UNII (FDA Substance ID)

0I55128JYK

THEOPHYLLINE ANHYDROUS

RxCUI 91178

Orange Book

A090355

ABAB

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": "68462-380_7c8e32e3-ca36-4ad2-971b-446c12a81992",
  "productndc": "68462-380",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "090355",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Jul 13, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Jul 13, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "THEOPHYLLINE ANHYDROUS",
  "proprietary_name": "Theophylline",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090355",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Theophylline",
  "start_marketing_date": "20100713",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code R03DA04.

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