Carbidopa and Levodopa

Orange BookUNIISPLATC N04BA

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC

CountryUS (United States)

ATC codeN04BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6021920331
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2033-1)
ndc11
6021920333
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2033-3)
ndc11
6021920335
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2033-5)

Annotations

UNII (FDA Substance ID)

MNX7R8C5VO

CARBIDOPA HYDRATE

RxCUI 2019

Orange Book

A076521

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "MNX7R8C5VO",
    "rxcui": "2019",
    "inchikey": "QTAOMKOIBXZKND-PPHPATTJSA-N",
    "display_name": "CARBIDOPA HYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "87ab55c9-203d-d595-3e3e-0e38f2f6d9c4": {
      "match": "brand_token",
      "title": "CARBIDOPA AND LEVODOPA TABLET [DR. REDDY'S LABORATORIES INC]",
      "spl_version": "4",
      "published_date": "2026-05-21"
    }
  },
  "productid": "60219-2033_b5ad7e75-c6cd-4b2d-a3bf-e2e860d5b9c1",
  "productndc": "60219-2033",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "076521",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;100MG",
        "product_no": "001",
        "approval_date": "May 14, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG;200MG",
        "product_no": "002",
        "approval_date": "May 14, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBIDOPA HYDRATE; LEVODOPA",
  "proprietary_name": "Carbidopa and Levodopa",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA076521",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CARBIDOPA and LEVODOPA",
  "start_marketing_date": "20221221",
  "active_numerator_strength": "25; 100"
}

Related drugs

Other records sharing ATC code N04BA.

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