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United States · US · US:0115-2622_63142944-3083-4d47-908f-2984144b6c5d

TERBUTALINE SULFATE

Orange BookUNIISPLATC R03CC53

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeR03CC53
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0115262201
    100 TABLET in 1 BOTTLE (0115-2622-01)
  • ndc11
    0115262202
    500 TABLET in 1 BOTTLE (0115-2622-02)

Annotations

UNII (FDA Substance ID)
576PU70Y8E
TERBUTALINE SULFATE
RxCUI 10369
Orange Book
A075877
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": "0115-2622_63142944-3083-4d47-908f-2984144b6c5d",
  "productndc": "0115-2622",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075877",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Jun 26, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Jun 26, 2001"
      }
    ],
    "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": "ANDA075877",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TERBUTALINE SULFATE",
  "start_marketing_date": "20010626",
  "active_numerator_strength": "5"
}

Related drugs

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