NDC 55111-163 – Olanzapine
Olanzapine 2.5 mg/1 · Tablet, Film Coated · Oral
Product NDC55111-163
Product details
- Brand name
- Olanzapine
- Generic name
- Olanzapine
- Labeler
- Dr. Reddy's Laboratories Ltd.
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA076255
- Marketed since
- April 23, 2012
- Listing expires
- December 31, 2026
- Pharmacologic class
- Atypical Antipsychotic
Active ingredients
- Olanzapine 2.5 mg/1
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 55111-163-01 | 100 TABLET, FILM COATED in 1 BOTTLE (55111-163-01) | Apr 23, 2012 |
| 55111-163-05 | 500 TABLET, FILM COATED in 1 BOTTLE (55111-163-05) | Apr 23, 2012 |
| 55111-163-30 | 30 TABLET, FILM COATED in 1 BOTTLE (55111-163-30) | Apr 23, 2012 |
| 55111-163-78 | 10 BLISTER PACK in 1 CARTON (55111-163-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-163-79) | Apr 23, 2012 |
Recalls mentioning this NDC
- D-0468-2017 Feb 15, 2017 · Class III
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
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