NDC 69097-319 – Budesonide Inhalation Suspension
Budesonide .5 mg/2mL · Inhalant · Oral
Product NDC69097-319
Product details
- Brand name
- Budesonide Inhalation Suspension
- Generic name
- Budesonide
- Labeler
- Cipla USA Inc.
- Dosage form
- Inhalant
- Route
- Oral
- Marketing category
- ANDA · ANDA205710
- Marketed since
- November 16, 2017
- Listing expires
- December 31, 2027
- Pharmacologic class
- Corticosteroid
Active ingredients
- Budesonide .5 mg/2mL
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 69097-319-53 | 30 POUCH in 1 CARTON (69097-319-53) / 1 AMPULE in 1 POUCH (69097-319-32) / 2 mL in 1 AMPULE | Apr 10, 2020 |
| 69097-319-87 | 6 POUCH in 1 CARTON (69097-319-87) / 5 AMPULE in 1 POUCH (69097-319-86) / 2 mL in 1 AMPULE | Nov 16, 2017 |
Recalls mentioning this NDC
- D-0541-2025 Jul 30, 2025 · Class II
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. - D-1545-2022 Oct 5, 2022 · Class II
Lack of Assurance of Sterility
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