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United States · US · US:0591-2475_e13661d8-d500-46cd-995d-529adac77bda

Tetracycline Hydrochloride

Orange BookUNIISPLATC D06AA04

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeD06AA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0591247501
    100 CAPSULE in 1 BOTTLE, PLASTIC (0591-2475-01)

Annotations

UNII (FDA Substance ID)
P6R62377KV
TETRACYCLINE HYDROCHLORIDE
RxCUI 142446
Orange Book
A061837
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "P6R62377KV",
    "rxcui": "142446",
    "inchikey": "XMEVHPAGJVLHIG-FMZCEJRJSA-N",
    "display_name": "TETRACYCLINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d48071a0-c397-42f8-b8ad-158282e745e3": {
      "match": "brand_token",
      "title": "TETRACYCLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]",
      "spl_version": "1",
      "published_date": "2026-05-29"
    }
  },
  "productid": "0591-2475_e13661d8-d500-46cd-995d-529adac77bda",
  "productndc": "0591-2475",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "061837",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TETRACYCLINE HYDROCHLORIDE",
  "proprietary_name": "Tetracycline Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA061837",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tetracycline Hydrochloride",
  "start_marketing_date": "20110815",
  "active_numerator_strength": "500"
}

Related drugs

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