NDC 0069-0469 – Chantix
Varenicline Tartrate 1 mg/1 · Tablet, Film Coated · Oral
Product NDC0069-0469
Product details
- Brand name
- Chantix
- Generic name
- Varenicline tartrate
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- NDA · NDA021928
- Marketed since
- May 10, 2006
- Listing expires
- December 31, 2027
- Pharmacologic class
- Cholinergic Receptor Agonist; Partial Cholinergic Nicotinic Agonist
Active ingredients
- Varenicline Tartrate 1 mg/1
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 0069-0469-28 | 56 TABLET, FILM COATED in 1 BLISTER PACK (0069-0469-28) | Sep 22, 2025 |
| 0069-0469-56 | 56 TABLET, FILM COATED in 1 BOTTLE (0069-0469-56) | May 10, 2006 |
Recalls mentioning this NDC
- D-0810-2021 Sep 29, 2021 · Class II
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit - D-0811-2021 Sep 29, 2021 · Class II
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit - D-0809-2021 Sep 29, 2021 · Class II
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit - D-0699-2021 Aug 11, 2021 · Class II
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit - D-0701-2021 Aug 11, 2021 · Class II
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit - D-0700-2021 Aug 11, 2021 · Class II
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit - D-0555-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - D-0556-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - D-0554-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other Chantix products
- 43353-899 Varenicline Tartrate 1 mg/1 · Tablet, Film Coated · Aphena Pharma Solutions - Tennessee, LLC
- 0069-0468 Varenicline Tartrate .5 mg/1 · Tablet, Film Coated · Pfizer Laboratories Div Pfizer Inc
- 71205-381 Varenicline Tartrate 1 mg/1 · Tablet, Film Coated · Proficient Rx LP
- 0069-0471 · Kit · Pfizer Laboratories Div Pfizer Inc
- 63187-618 · Kit · Proficient Rx LP