Back to search
🇺🇸

United States · US · US:21130-158_14aa89a7-5eb1-4037-a169-cbb527b46e95

Pseudoephedrine HCl

Orange BookUNIISPLATC R01BA52

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

Identification

ManufacturerBetter Living Brands LLC
CountryUS (United States)
ATC codeR01BA52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2113015867
    2 BLISTER PACK in 1 CARTON (21130-158-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
6V9V2RYJ8N
PSEUDOEPHEDRINE HYDROCHLORIDE
RxCUI 91168
Orange Book
A209008
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": "21130-158_14aa89a7-5eb1-4037-a169-cbb527b46e95",
  "productndc": "21130-158",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "209008",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Jun 9, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "Pseudoephedrine HCl",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209008",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pseudoephedrine HCl",
  "start_marketing_date": "20230901",
  "active_numerator_strength": "120"
}

Related drugs

Other records sharing ATC code R01BA52.

Access this data programmatically

Query Pseudoephedrine HCl and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.