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
4359848610
4 BOTTLE in 1 CARTON (43598-486-10) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848612
5 BOTTLE in 1 CARTON (43598-486-12) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848613
5 BOTTLE in 1 CARTON (43598-486-13) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848614
6 BOTTLE in 1 CARTON (43598-486-14) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848616
6 BOTTLE in 1 CARTON (43598-486-16) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848617
7 BOTTLE in 1 CARTON (43598-486-17) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848618
7 BOTTLE in 1 CARTON (43598-486-18) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848619
8 BOTTLE in 1 CARTON (43598-486-19) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848622
10 BOTTLE in 1 CARTON (43598-486-22) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848623
8 BOTTLE in 1 CARTON (43598-486-23) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848624
1 BOTTLE in 1 CARTON (43598-486-24) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848627
1 BOTTLE in 1 CARTON (43598-486-27) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848629
10 BOTTLE in 1 CARTON (43598-486-29) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848648
2 BOTTLE in 1 CARTON (43598-486-48) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848654
2 BOTTLE in 1 CARTON (43598-486-54) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848672
3 BOTTLE in 1 CARTON (43598-486-72) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848673
7 BOTTLE in 1 CARTON (43598-486-73) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848674
7 BOTTLE in 1 CARTON (43598-486-74) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848681
3 BOTTLE in 1 CARTON (43598-486-81) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848696
4 BOTTLE in 1 CARTON (43598-486-96) / 24 LOZENGE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

6M3C89ZY6R

NICOTINE

RxCUI 7407

Orange Book

A212796

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": "43598-486_33e2c1b3-2ea4-98f4-47c2-320c8ddd608e",
  "productndc": "43598-486",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "212796",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Jan 8, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Jan 8, 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": "ANDA212796",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine Polacrilex",
  "start_marketing_date": "20200609",
  "active_numerator_strength": "2"
}

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