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United States · US · US:71205-938_9f8ee6b8-61e1-478a-90de-57358fdb5905

Terbutaline Sulfate

Orange BookUNIISPLATC R03CC53

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeR03CC53
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7120593800
    100 TABLET in 1 BOTTLE (71205-938-00)
  • ndc11
    7120593830
    30 TABLET in 1 BOTTLE (71205-938-30)
  • ndc11
    7120593855
    500 TABLET in 1 BOTTLE (71205-938-55)
  • ndc11
    7120593860
    60 TABLET in 1 BOTTLE (71205-938-60)
  • ndc11
    7120593890
    90 TABLET in 1 BOTTLE (71205-938-90)

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": "71205-938_9f8ee6b8-61e1-478a-90de-57358fdb5905",
  "productndc": "71205-938",
  "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"
}

Related drugs

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