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United States · US · US:0527-1318_75d6b891-2c50-4748-829a-3567ee966978

Terbutaline Sulfate

Orange BookUNIISPLATC R03CC53

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

Identification

ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeR03CC53
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0527131801
    100 TABLET in 1 BOTTLE (0527-1318-01)
  • ndc11
    0527131810
    1000 TABLET in 1 BOTTLE (0527-1318-10)

Annotations

UNII (FDA Substance ID)
576PU70Y8E
TERBUTALINE SULFATE
RxCUI 10369
Orange Book
A077152
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "576PU70Y8E",
    "rxcui": "10369",
    "inchikey": "KFVSLSTULZVNPG-UHFFFAOYSA-N",
    "display_name": "TERBUTALINE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "859267c6-3d14-4123-9b9d-4fc248f09726": {
      "match": "brand_token",
      "title": "TERBUTALINE SULFATE TABLET [CHARTWELL RX, LLC.]",
      "spl_version": "2",
      "published_date": "2025-12-12"
    }
  },
  "productid": "0527-1318_75d6b891-2c50-4748-829a-3567ee966978",
  "productndc": "0527-1318",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077152",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Mar 25, 2005"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Mar 25, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERBUTALINE SULFATE",
  "proprietary_name": "Terbutaline Sulfate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077152",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Terbutaline Sulfate",
  "start_marketing_date": "20050325",
  "active_numerator_strength": "2.5"
}

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