OFLOXACIN

Orange BookUNIISPLATC J01MA01

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

Identification

ManufacturerNivagen Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeJ01MA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7583419901
100 TABLET, COATED in 1 BOTTLE (75834-199-01)
ndc11
7583419905
500 TABLET, COATED in 1 BOTTLE (75834-199-05)
ndc11
7583419950
50 TABLET, COATED in 1 BOTTLE (75834-199-50)

Annotations

UNII (FDA Substance ID)

A4P49JAZ9H

OFLOXACIN

RxCUI 7623

Orange Book

A091656

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "A4P49JAZ9H",
    "rxcui": "7623",
    "inchikey": "GSDSWSVVBLHKDQ-UHFFFAOYSA-N",
    "display_name": "OFLOXACIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d97651cc-d9ea-4be4-8ea1-3d0278582dd5": {
      "match": "brand_token",
      "title": "OFLOXACIN SOLUTION/ DROPS [REMEDYREPACK INC.]",
      "spl_version": "7",
      "published_date": "2026-04-17"
    }
  },
  "productid": "75834-199_991170ff-e65c-421f-b7f0-95f78e459844",
  "productndc": "75834-199",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "091656",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Sep 18, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Sep 18, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Sep 18, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OFLOXACIN",
  "proprietary_name": "OFLOXACIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091656",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OFLOXACIN",
  "start_marketing_date": "20190125",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code J01MA01.

Access this data programmatically

Query OFLOXACIN 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.

Get a free API key Read the API docs