Tetracycline Hydrochloride

Orange BookUNIISPLATC D06AA04

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

Identification

ManufacturerPharmaka Generics Inc.

CountryUS (United States)

ATC codeD06AA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8264487060
60 TABLET, FILM COATED in 1 BOTTLE (82644-870-60)

Annotations

UNII (FDA Substance ID)

P6R62377KV

TETRACYCLINE HYDROCHLORIDE

RxCUI 142446

Orange Book

A061147

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": "82644-870_3d44a562-4fde-4867-90e6-433ea752bb3c",
  "productndc": "82644-870",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "061147",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "500MG",
        "product_no": "004",
        "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": "ANDA061147",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tetracycline Hydrochloride",
  "start_marketing_date": "20240119",
  "active_numerator_strength": "500"
}

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