Nicotine Polacrilex

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerDr. Reddy's Laboratories Inc.

CountryUS (United States)

ATC codeN07BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 20

ndc11
4359848910
4 BOTTLE in 1 CARTON (43598-489-10) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848912
5 BOTTLE in 1 CARTON (43598-489-12) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848913
5 BOTTLE in 1 CARTON (43598-489-13) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848914
6 BOTTLE in 1 CARTON (43598-489-14) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848916
6 BOTTLE in 1 CARTON (43598-489-16) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848917
7 BOTTLE in 1 CARTON (43598-489-17) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848918
7 BOTTLE in 1 CARTON (43598-489-18) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848919
8 BOTTLE in 1 CARTON (43598-489-19) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848922
10 BOTTLE in 1 CARTON (43598-489-22) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848923
8 BOTTLE in 1 CARTON (43598-489-23) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848924
1 BOTTLE in 1 CARTON (43598-489-24) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848927
1 BOTTLE in 1 CARTON (43598-489-27) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848929
10 BOTTLE in 1 CARTON (43598-489-29) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848948
2 BOTTLE in 1 CARTON (43598-489-48) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848954
2 BOTTLE in 1 CARTON (43598-489-54) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848972
3 BOTTLE in 1 CARTON (43598-489-72) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848973
7 BOTTLE in 1 CARTON (43598-489-73) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848974
7 BOTTLE in 1 CARTON (43598-489-74) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848981
3 BOTTLE in 1 CARTON (43598-489-81) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848996
4 BOTTLE in 1 CARTON (43598-489-96) / 24 LOZENGE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

6M3C89ZY6R

NICOTINE

RxCUI 7407

Orange Book

A213233

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6M3C89ZY6R",
    "rxcui": "7407",
    "inchikey": "SNICXCGAKADSCV-JTQLQIEISA-N",
    "display_name": "NICOTINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f1eb8d9f-1c9a-4c8a-833b-ced0ec01ed5c": {
      "match": "brand_token",
      "title": "NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]",
      "spl_version": "5",
      "published_date": "2026-06-01"
    }
  },
  "productid": "43598-489_ea14d88d-2ad8-b2e9-bf8f-8a299e66d618",
  "productndc": "43598-489",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "213233",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Aug 4, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Aug 4, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "Nicotine Polacrilex",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213233",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine Polacrilex",
  "start_marketing_date": "20201001",
  "active_numerator_strength": "4"
}

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