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
4359848810
4 BOTTLE in 1 CARTON (43598-488-10) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848812
5 BOTTLE in 1 CARTON (43598-488-12) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848813
5 BOTTLE in 1 CARTON (43598-488-13) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848814
6 BOTTLE in 1 CARTON (43598-488-14) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848816
6 BOTTLE in 1 CARTON (43598-488-16) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848817
7 BOTTLE in 1 CARTON (43598-488-17) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848818
7 BOTTLE in 1 CARTON (43598-488-18) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848819
8 BOTTLE in 1 CARTON (43598-488-19) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848822
10 BOTTLE in 1 CARTON (43598-488-22) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848823
8 BOTTLE in 1 CARTON (43598-488-23) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848824
1 BOTTLE in 1 CARTON (43598-488-24) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848827
1 BOTTLE in 1 CARTON (43598-488-27) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848829
10 BOTTLE in 1 CARTON (43598-488-29) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848848
2 BOTTLE in 1 CARTON (43598-488-48) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848854
2 BOTTLE in 1 CARTON (43598-488-54) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848872
3 BOTTLE in 1 CARTON (43598-488-72) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848873
7 BOTTLE in 1 CARTON (43598-488-73) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848874
7 BOTTLE in 1 CARTON (43598-488-74) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848881
3 BOTTLE in 1 CARTON (43598-488-81) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848896
4 BOTTLE in 1 CARTON (43598-488-96) / 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": "43598-488_ea14d88d-2ad8-b2e9-bf8f-8a299e66d618",
  "productndc": "43598-488",
  "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": "2"
}

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