Albuterol Sulfate
- Product NDC
- 0378-4124
- 11-digit product format
- 003784124
- Labeler code
- 0378
- Product ID
- 0378-4124_ede2f497-8313-48c6-9ff4-0a012d0fd6b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- albuterol sulfate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA078092
- Marketing category
- ANDA
- Marketing start
- 2007-01-30
- Marketing end
- 0000-00-00
- Substance
- ALBUTEROL SULFATE
- Active strength
- 8 mg/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-4124-01 | 00378412401 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4124-01) | 2007-01-30 | 0000-00-00 | No | No | Current |