Acetylcysteine
- Product NDC
- 51754-0104
- 11-digit product format
- 517540104
- Labeler code
- 51754
- Product ID
- 51754-0104_1ec6f467-e66b-406a-ba60-bd4c5ce8fbaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetylcysteine Injection
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Exela Pharma Sciences, LLC
- Application
- ANDA204797
- Marketing category
- ANDA
- Marketing start
- 2021-07-16
- 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
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51754-0104 | ACETYLCYSTEINE (ACETYLCYSTEINE INJECTION) INJECTION [EXELA PHARMA SCIENCES, LLC] | 1 | Legacy NDC | 20210717_4505de2a-ef6f-4bb7-9845-1228afbe0a0e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51754-0104-7 | 51754010407 | 4 VIAL in 1 CARTON (51754-0104-7) > 30 mL in 1 VIAL | 4 vial | 2021-07-16 | 0000-00-00 | No | No | Current |