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 · 19

ndc11
4359848712
5 BOTTLE in 1 CARTON (43598-487-12) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848713
5 BOTTLE in 1 CARTON (43598-487-13) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848714
6 BOTTLE in 1 CARTON (43598-487-14) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848716
6 BOTTLE in 1 CARTON (43598-487-16) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848717
7 BOTTLE in 1 CARTON (43598-487-17) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848718
7 BOTTLE in 1 CARTON (43598-487-18) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848719
8 BOTTLE in 1 CARTON (43598-487-19) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848722
10 BOTTLE in 1 CARTON (43598-487-22) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848723
8 BOTTLE in 1 CARTON (43598-487-23) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848724
1 BOTTLE in 1 CARTON (43598-487-24) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848727
1 BOTTLE in 1 CARTON (43598-487-27) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848729
10 BOTTLE in 1 CARTON (43598-487-29) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848748
2 BOTTLE in 1 CARTON (43598-487-48) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848754
2 BOTTLE in 1 CARTON (43598-487-54) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848772
3 BOTTLE in 1 CARTON (43598-487-72) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848773
7 BOTTLE in 1 CARTON (43598-487-73) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848774
7 BOTTLE in 1 CARTON (43598-487-74) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848781
3 BOTTLE in 1 CARTON (43598-487-81) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848796
4 BOTTLE in 1 CARTON (43598-487-96) / 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": "43598-487_33e2c1b3-2ea4-98f4-47c2-320c8ddd608e",
  "productndc": "43598-487",
  "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": "4"
}

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