Budesonide
- Product NDC
- 36800-113
- 11-digit product format
- 368000113
- Labeler code
- 36800
- Product ID
- 36800-113_d62f9dea-a0c4-7b85-e1a3-858d6a0e4d6d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Topco Associates LLC
- Application
- ANDA078949
- Marketing category
- ANDA
- Marketing start
- 2016-08-31
- Marketing end
- 2020-07-31
- Substance
- BUDESONIDE
- Active strength
- 32 ug/1
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record