Fexofenadine hydrochloride

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerDr. Reddy's Laboratories Limited

CountryUS (United States)

ATC codeR06AX26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 17

ndc11
5511178401
1 BOTTLE in 1 CARTON (55111-784-01) / 100 TABLET in 1 BOTTLE
ndc11
5511178405
1 BOTTLE in 1 CARTON (55111-784-05) / 500 TABLET in 1 BOTTLE
ndc11
5511178407
1 BLISTER PACK in 1 CARTON (55111-784-07) / 5 TABLET in 1 BLISTER PACK
ndc11
5511178415
1 BOTTLE in 1 CARTON (55111-784-15) / 150 TABLET in 1 BOTTLE
ndc11
5511178418
1 BOTTLE in 1 CARTON (55111-784-18) / 180 TABLET in 1 BOTTLE
ndc11
5511178423
1 BLISTER PACK in 1 CARTON (55111-784-23) / 2 TABLET in 1 BLISTER PACK
ndc11
5511178428
3 BLISTER PACK in 1 CARTON (55111-784-28) / 15 TABLET in 1 BLISTER PACK
ndc11
5511178429
3 BLISTER PACK in 1 CARTON (55111-784-29) / 5 TABLET in 1 BLISTER PACK
ndc11
5511178430
1 BOTTLE in 1 CARTON (55111-784-30) / 30 TABLET in 1 BOTTLE
ndc11
5511178435
2 BLISTER PACK in 1 CARTON (55111-784-35) / 5 TABLET in 1 BLISTER PACK
ndc11
5511178440
1 BOTTLE in 1 CARTON (55111-784-40) / 40 TABLET in 1 BOTTLE
ndc11
5511178443
2 BOTTLE in 1 CARTON (55111-784-43) / 30 TABLET in 1 BOTTLE
ndc11
5511178445
1 BOTTLE in 1 CARTON (55111-784-45) / 45 TABLET in 1 BOTTLE
ndc11
5511178459
2 BOTTLE in 1 CARTON (55111-784-59) / 60 TABLET in 1 BOTTLE
ndc11
5511178475
1 BOTTLE in 1 CARTON (55111-784-75) / 70 TABLET in 1 BOTTLE
ndc11
5511178478
10 BLISTER PACK in 1 CARTON (55111-784-78) / 10 TABLET in 1 BLISTER PACK (55111-784-79)
ndc11
5511178490
1 BOTTLE in 1 CARTON (55111-784-90) / 90 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

2S068B75ZU

FEXOFENADINE HYDROCHLORIDE

RxCUI 236474

Orange Book

A076502

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "2S068B75ZU",
    "rxcui": "236474",
    "inchikey": "RRJFVPUCXDGFJB-UHFFFAOYSA-N",
    "display_name": "FEXOFENADINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52d50976-e63a-b3e3-e063-6294a90a6a97": {
      "match": "brand_token",
      "title": "FEXOFENADINE HCL TABLET [YYBA CORP]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "55111-784_9c0b82c6-7eff-3eec-40e2-db72a8625eff",
  "productndc": "55111-784",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076502",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Apr 11, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "Apr 11, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "003",
        "approval_date": "Apr 11, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "004",
        "approval_date": "Apr 12, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "005",
        "approval_date": "Apr 12, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "006",
        "approval_date": "Apr 12, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "007",
        "approval_date": "Apr 12, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "008",
        "approval_date": "Apr 12, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "009",
        "approval_date": "Apr 12, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FEXOFENADINE HYDROCHLORIDE",
  "proprietary_name": "Fexofenadine hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076502",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fexofenadine hydrochloride",
  "start_marketing_date": "20110103",
  "active_numerator_strength": "180"
}

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