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United States · US · US:51991-907_a8cfae79-912a-40ad-99b3-02510f5b7bed

Tetracycline Hydrochloride

Orange BookUNIISPLATC D06AA04

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

Identification

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

Packs · 3

  • ndc11
    5199190701
    100 CAPSULE in 1 BOTTLE, PLASTIC (51991-907-01)
  • ndc11
    5199190705
    500 CAPSULE in 1 BOTTLE, PLASTIC (51991-907-05)
  • ndc11
    5199190733
    30 CAPSULE in 1 BOTTLE, PLASTIC (51991-907-33)

Annotations

UNII (FDA Substance ID)
P6R62377KV
TETRACYCLINE HYDROCHLORIDE
RxCUI 142446
Orange Book
A210662
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": "51991-907_a8cfae79-912a-40ad-99b3-02510f5b7bed",
  "productndc": "51991-907",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "210662",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Nov 7, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Nov 7, 2018"
      }
    ],
    "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": "ANDA210662",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tetracycline Hydrochloride",
  "start_marketing_date": "20190118",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code D06AA04.

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