Theo-24

Orange BookUNIISPLATC R03DA04

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

Identification

ManufacturerENDO USA, Inc.

CountryUS (United States)

ATC codeR03DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5224420010
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-200-10)

Annotations

UNII (FDA Substance ID)

0I55128JYK

THEOPHYLLINE ANHYDROUS

RxCUI 91178

Orange Book

A087943

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": {
    "7a108fa0-c230-475f-be93-6f864b98a410": {
      "match": "brand_token",
      "title": "THEO-24 (THEOPHYLLINE ANHYDROUS) CAPSULE, EXTENDED RELEASE [ENDO USA, INC.]",
      "spl_version": "11",
      "published_date": "2024-07-09"
    }
  },
  "productid": "52244-200_95d19693-50ba-43fc-81fe-6cddc537703a",
  "productndc": "52244-200",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "087943",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Aug 22, 1983"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Aug 22, 1983"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Aug 22, 1983"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "400MG",
        "product_no": "004",
        "approval_date": "Feb 28, 1992"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "THEOPHYLLINE ANHYDROUS",
  "proprietary_name": "Theo-24",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA087943",
  "marketing_category": "ANDA",
  "nonproprietary_name": "theophylline anhydrous",
  "start_marketing_date": "20140825",
  "active_numerator_strength": "200"
}

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