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United States · US · US:71335-1921_fc76e96e-9ce8-de0f-e053-6294a90a0eb2

Loperamide Hydrochloride

Orange BookUNIISPLATC A07DA03

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeA07DA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    7133519210
    50 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-0)
  • ndc11
    7133519211
    15 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-1)
  • ndc11
    7133519212
    30 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-2)
  • ndc11
    7133519213
    20 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-3)
  • ndc11
    7133519214
    12 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-4)
  • ndc11
    7133519215
    60 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-5)
  • ndc11
    7133519216
    24 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-6)
  • ndc11
    7133519217
    14 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-7)
  • ndc11
    7133519218
    9 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-8)
  • ndc11
    7133519219
    5 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-9)

Annotations

UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A072741
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "77TI35393C",
    "rxcui": "82038",
    "inchikey": "PGYPOBZJRVSMDS-UHFFFAOYSA-N",
    "display_name": "LOPERAMIDE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0b1f8d41-51b3-4362-8de7-46bca5caff12": {
      "match": "brand_token",
      "title": "LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "6",
      "published_date": "2026-06-01"
    }
  },
  "productid": "71335-1921_fc76e96e-9ce8-de0f-e053-6294a90a0eb2",
  "productndc": "71335-1921",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "072741",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Sep 18, 1991"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "Loperamide Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA072741",
  "marketing_category": "ANDA",
  "nonproprietary_name": "loperamide hydrochloride",
  "start_marketing_date": "19910918",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code A07DA03.

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