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
4359848410
4 BOTTLE in 1 CARTON (43598-484-10) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848412
5 BOTTLE in 1 CARTON (43598-484-12) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848413
5 BOTTLE in 1 CARTON (43598-484-13) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848414
6 BOTTLE in 1 CARTON (43598-484-14) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848416
6 BOTTLE in 1 CARTON (43598-484-16) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848417
7 BOTTLE in 1 CARTON (43598-484-17) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848418
7 BOTTLE in 1 CARTON (43598-484-18) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848419
8 BOTTLE in 1 CARTON (43598-484-19) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848422
10 BOTTLE in 1 CARTON (43598-484-22) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848423
8 BOTTLE in 1 CARTON (43598-484-23) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848424
1 BOTTLE in 1 CARTON (43598-484-24) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848427
1 BOTTLE in 1 CARTON (43598-484-27) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848429
10 BOTTLE in 1 CARTON (43598-484-29) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848448
2 BOTTLE in 1 CARTON (43598-484-48) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848454
2 BOTTLE in 1 CARTON (43598-484-54) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848472
3 BOTTLE in 1 CARTON (43598-484-72) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848473
7 BOTTLE in 1 CARTON (43598-484-73) / 24 LOZENGE in 1 BOTTLE
ndc11
4359848474
7 BOTTLE in 1 CARTON (43598-484-74) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848481
3 BOTTLE in 1 CARTON (43598-484-81) / 27 LOZENGE in 1 BOTTLE
ndc11
4359848496
4 BOTTLE in 1 CARTON (43598-484-96) / 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": "43598-484_1ae4bead-7050-e5ac-74ee-bcb145e68af8",
  "productndc": "43598-484",
  "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": "2"
}

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