theophylline

Orange BookUNIISPLATC R03DA04

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC

CountryUS (United States)

ATC codeR03DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6021920451
100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-1)
ndc11
6021920453
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-3)
ndc11
6021920455
500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-5)
ndc11
6021920457
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-7)

Annotations

UNII (FDA Substance ID)

0I55128JYK

THEOPHYLLINE ANHYDROUS

RxCUI 91178

Orange Book

A216276

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": "60219-2045_8d9dfe98-c0ba-44aa-a349-33c8d0a8bbdf",
  "productndc": "60219-2045",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "216276",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "001",
        "approval_date": "Mar 20, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "450MG",
        "product_no": "002",
        "approval_date": "Mar 20, 2023"
      }
    ],
    "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": "ANDA216276",
  "marketing_category": "ANDA",
  "nonproprietary_name": "theophylline",
  "start_marketing_date": "20230327",
  "active_numerator_strength": "300"
}

Related drugs

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