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
4359848510
4 BOTTLE in 1 CARTON (43598-485-10) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848512
5 BOTTLE in 1 CARTON (43598-485-12) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848513
5 BOTTLE in 1 CARTON (43598-485-13) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848514
6 BOTTLE in 1 CARTON (43598-485-14) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848516
6 BOTTLE in 1 CARTON (43598-485-16) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848517
7 BOTTLE in 1 CARTON (43598-485-17) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848518
7 BOTTLE in 1 CARTON (43598-485-18) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848519
8 BOTTLE in 1 CARTON (43598-485-19) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848522
10 BOTTLE in 1 CARTON (43598-485-22) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848523
8 BOTTLE in 1 CARTON (43598-485-23) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848524
1 BOTTLE in 1 CARTON (43598-485-24) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848527
1 BOTTLE in 1 CARTON (43598-485-27) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848529
10 BOTTLE in 1 CARTON (43598-485-29) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848548
2 BOTTLE in 1 CARTON (43598-485-48) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848554
2 BOTTLE in 1 CARTON (43598-485-54) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848572
3 BOTTLE in 1 CARTON (43598-485-72) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848573
7 BOTTLE in 1 CARTON (43598-485-73) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848574
7 BOTTLE in 1 CARTON (43598-485-74) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848581
3 BOTTLE in 1 CARTON (43598-485-81) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848596
4 BOTTLE in 1 CARTON (43598-485-96) / 24 LOZENGE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

6M3C89ZY6R

NICOTINE

RxCUI 7407

Orange Book

A212983

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": "43598-485_1ae4bead-7050-e5ac-74ee-bcb145e68af8",
  "productndc": "43598-485",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "212983",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Feb 21, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Feb 21, 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": "ANDA212983",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine Polacrilex",
  "start_marketing_date": "20200911",
  "active_numerator_strength": "4"
}

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