NDC 47335-633 – Budesonide
Budesonide 1 mg/2mL · Suspension · Respiratory (inhalation)
Product NDC47335-633
Product details
- Brand name
- Budesonide
- Generic name
- Budesonide
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Dosage form
- Suspension
- Route
- Respiratory (inhalation)
- Marketing category
- ANDA · ANDA211922
- Marketed since
- May 1, 2021
- Listing expires
- December 31, 2027
- Pharmacologic class
- Corticosteroid
Active ingredients
- Budesonide 1 mg/2mL
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 47335-633-49 | 6 POUCH in 1 CARTON (47335-633-49) / 5 AMPULE in 1 POUCH (47335-633-48) / 2 mL in 1 AMPULE | May 1, 2021 |
Recalls mentioning this NDC
- D-0607-2026 Jun 17, 2026 · Class II
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
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- 62135-822 Budesonide .25 mg/2mL · Suspension · Chartwell RX, LLC
- 47335-632 Budesonide .5 mg/2mL · Suspension · Sun Pharmaceutical Industries, Inc.
- 47335-631 Budesonide .25 mg/2mL · Suspension · Sun Pharmaceutical Industries, Inc.
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