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United States · US · US:24979-132_3fd94b35-ef5a-4eb3-a3bd-0ce7572521d6

Terbutaline Sulfate

Orange BookUNIISPLATC R03CC53

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeR03CC53
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2497913201
    100 TABLET in 1 BOTTLE (24979-132-01)
  • ndc11
    2497913203
    1000 TABLET in 1 BOTTLE (24979-132-03)

Annotations

UNII (FDA Substance ID)
576PU70Y8E
TERBUTALINE SULFATE
RxCUI 10369
Orange Book
A211832
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": "24979-132_3fd94b35-ef5a-4eb3-a3bd-0ce7572521d6",
  "productndc": "24979-132",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211832",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Jun 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Jun 19, 2020"
      }
    ],
    "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": "ANDA211832",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Terbutaline Sulfate",
  "start_marketing_date": "20200713",
  "active_numerator_strength": "2.5"
}

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