Tramadol Hydrochloride

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeN02AX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 23

ndc11
7161086515
15 TABLET, FILM COATED in 1 BOTTLE (71610-865-15)
ndc11
7161086520
20 TABLET, FILM COATED in 1 BOTTLE (71610-865-20)
ndc11
7161086524
224 TABLET, FILM COATED in 1 BOTTLE (71610-865-24)
ndc11
7161086528
28 TABLET, FILM COATED in 1 BOTTLE (71610-865-28)
ndc11
7161086530
30 TABLET, FILM COATED in 1 BOTTLE (71610-865-30)
ndc11
7161086540
40 TABLET, FILM COATED in 1 BOTTLE (71610-865-40)
ndc11
7161086545
45 TABLET, FILM COATED in 1 BOTTLE (71610-865-45)
ndc11
7161086546
56 TABLET, FILM COATED in 1 BOTTLE (71610-865-46)
ndc11
7161086550
50 TABLET, FILM COATED in 1 BOTTLE (71610-865-50)
ndc11
7161086553
60 TABLET, FILM COATED in 1 BOTTLE (71610-865-53)
ndc11
7161086554
84 TABLET, FILM COATED in 1 BOTTLE (71610-865-54)
ndc11
7161086557
80 TABLET, FILM COATED in 1 BOTTLE (71610-865-57)
ndc11
7161086560
90 TABLET, FILM COATED in 1 BOTTLE (71610-865-60)
ndc11
7161086565
100 TABLET, FILM COATED in 1 BOTTLE (71610-865-65)
ndc11
7161086567
168 TABLET, FILM COATED in 1 BOTTLE (71610-865-67)
ndc11
7161086570
120 TABLET, FILM COATED in 1 BOTTLE (71610-865-70)
ndc11
7161086572
112 TABLET, FILM COATED in 1 BOTTLE (71610-865-72)
ndc11
7161086573
135 TABLET, FILM COATED in 1 BOTTLE (71610-865-73)
ndc11
7161086575
150 TABLET, FILM COATED in 1 BOTTLE (71610-865-75)
ndc11
7161086580
180 TABLET, FILM COATED in 1 BOTTLE (71610-865-80)
ndc11
7161086585
200 TABLET, FILM COATED in 1 BOTTLE (71610-865-85)
ndc11
7161086590
240 TABLET, FILM COATED in 1 BOTTLE (71610-865-90)
ndc11
7161086592
270 TABLET, FILM COATED in 1 BOTTLE (71610-865-92)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A075977

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "9N7R477WCK",
    "rxcui": "82110",
    "inchikey": "PPKXEPBICJTCRU-XMZRARIVSA-N;PPKXEPBICJTCRU-KUARMEPBSA-N",
    "display_name": "TRAMADOL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a6cbd5de-8ae5-49e3-b89b-e35536b115d8": {
      "match": "brand_token",
      "title": "TRAMADOL HYDROCHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "71610-865_27460b14-190b-94e9-e063-6394a90ae97f",
  "productndc": "71610-865",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075977",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jun 19, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRAMADOL HYDROCHLORIDE",
  "proprietary_name": "Tramadol Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075977",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tramadol Hydrochloride",
  "start_marketing_date": "20020619",
  "active_numerator_strength": "50"
}

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