Duloxetine

Orange BookUNIISPLATC N06AX21

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN06AX21

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
3172216801
100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-01)
ndc11
3172216805
500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-05)
ndc11
3172216810
1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-10)
ndc11
3172216830
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-30)
ndc11
3172216831
7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (31722-168-31)
ndc11
3172216832
105 CAPSULE, DELAYED RELEASE in 1 CARTON (31722-168-32)
ndc11
3172216860
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-60)
ndc11
3172216890
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-90)

Annotations

UNII (FDA Substance ID)

9044SC542W

DULOXETINE HYDROCHLORIDE

RxCUI 476250

Orange Book

A204343

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "9044SC542W",
    "rxcui": "476250",
    "inchikey": "BFFSMCNJSOPUAY-LMOVPXPDSA-N",
    "display_name": "DULOXETINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9dab9154-b86f-40dc-a4d1-18e6534dbc78": {
      "match": "brand_token",
      "title": "DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]",
      "spl_version": "28",
      "published_date": "2026-05-20"
    }
  },
  "productid": "31722-168_232a4dda-8bb0-52fa-e063-6394a90ab09e",
  "productndc": "31722-168",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "204343",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Aug 3, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "002",
        "approval_date": "Aug 3, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "003",
        "approval_date": "Aug 3, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DULOXETINE HYDROCHLORIDE",
  "proprietary_name": "Duloxetine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204343",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Duloxetine",
  "start_marketing_date": "20201230",
  "active_numerator_strength": "20"
}

Related drugs

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