Acetylcysteine
- Product NDC
- 0517-7630
- 11-digit product format
- 005177630
- Labeler code
- 0517
- Product ID
- 0517-7630_d8c54054-153b-4e3a-9446-700b6f80bd6e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetylcysteine
- Dosage form
- INHALANT
- Route
- RESPIRATORY (INHALATION)
- Labeler
- American Regent, Inc.
- Application
- ANDA072547
- Marketing category
- ANDA
- Marketing start
- 1995-10-01
- Marketing end
- 0000-00-00
- Substance
- ACETYLCYSTEINE
- Active strength
- 200 mg/mL
- Pharmacologic classes
- Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0517-7630-03 | Acetylcysteine | 3 in 1 BOX | INHALANT | 3 | | 11 |
| 0517-7630-03 | Acetylcysteine | 30 mL in 1 VIAL, GLASS | INHALANT | 30 | | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0517-7630 | ACETYLCYSTEINE INHALANT [AMERICAN REGENT, INC.] | 11 | Legacy NDC, 2 package rows | 20241219_f56b4087-db48-4fd7-84ec-9c927962b805.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0517-7630-03 | 00517763003 | 3 VIAL, GLASS in 1 BOX (0517-7630-03) > 30 mL in 1 VIAL, GLASS | 1995-10-01 | 0000-00-00 | No | No | Current |