Pseudoephedrine hydrochloride

Orange BookUNIISPLATC R01BA52

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerOhm Laboratories Inc.

CountryUS (United States)

ATC codeR01BA52

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5166020421
20 TABLET, FILM COATED in 1 BLISTER PACK (51660-204-21)
ndc11
5166020469
10 TABLET, FILM COATED in 1 BLISTER PACK (51660-204-69)

Annotations

UNII (FDA Substance ID)

6V9V2RYJ8N

PSEUDOEPHEDRINE HYDROCHLORIDE

RxCUI 91168

Orange Book

A077442

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6V9V2RYJ8N",
    "rxcui": "91168",
    "inchikey": "BALXUFOVQVENIU-KXNXZCPBSA-N",
    "display_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3bf95c58-4fd9-4caa-a54f-2e61a5eacae8": {
      "match": "brand_token",
      "title": "PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC]",
      "spl_version": "2",
      "published_date": "2026-05-11"
    }
  },
  "productid": "51660-204_59b6d775-716c-41f4-b0e4-48324205671a",
  "productndc": "51660-204",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077442",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Sep 28, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "Pseudoephedrine hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077442",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pseudoephedrine hydrochloride",
  "start_marketing_date": "20060428",
  "active_numerator_strength": "120"
}

Related drugs

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