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United States · US · US:72162-1283_bbff7b05-68a1-4124-9dec-74f8f6cfd058

Hydrocodone Polistirex and Chlorpheniramine Polistirex

Orange BookUNIISPLATC R06AB

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeR06AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7216212832
    115 mL in 1 BOTTLE (72162-1283-2)
  • ndc11
    7216212834
    473 mL in 1 BOTTLE (72162-1283-4)

Annotations

UNII (FDA Substance ID)
V1Q0O9OJ9Z
CHLORPHENIRAMINE MALEATE
RxCUI 142429
Orange Book
A091632
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "V1Q0O9OJ9Z",
    "rxcui": "142429",
    "inchikey": "DBAKFASWICGISY-BTJKTKAUSA-N",
    "display_name": "CHLORPHENIRAMINE MALEATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1f9c1adc-f84f-43de-af5c-d93703aba7f8": {
      "match": "brand_token",
      "title": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RHODES PHARMACEUTICALS LLC]",
      "spl_version": "20",
      "published_date": "2026-06-01"
    }
  },
  "productid": "72162-1283_bbff7b05-68a1-4124-9dec-74f8f6cfd058",
  "productndc": "72162-1283",
  "dosage_form": "SUSPENSION, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "091632",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML",
        "product_no": "001",
        "approval_date": "Oct 1, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE",
  "proprietary_name": "Hydrocodone Polistirex and Chlorpheniramine Polistirex",
  "active_ingred_unit": "mg/5mL; mg/5mL",
  "application_number": "ANDA091632",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocodone Polistirex and Chlorpheniramine Polistirex",
  "start_marketing_date": "20150306",
  "active_numerator_strength": "8; 10"
}

Related drugs

Other records sharing ATC code R06AB.

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