Acetylcysteine
- Product NDC
- 63323-963
- 11-digit product format
- 633230963
- Labeler code
- 63323
- Product ID
- 63323-963_2d292664-30db-4cb4-8e38-21b5d684c635
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetylcysteine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA200644
- Marketing category
- ANDA
- Marketing start
- 2012-11-09
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetylcysteine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETYLCYSTEINE | 200 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WYQ7N0BPYC |
| Rxcui | 465377 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-963-21 | Acetylcysteine | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | | 13 |
| 63323-963-30 | Acetylcysteine | 4 in 1 CARTON | INJECTION, SOLUTION | 4 | | 13 |
| 63323-963-41 | Acetylcysteine | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | | 2 |
| 63323-963-44 | Acetylcysteine | 4 in 1 CARTON | INJECTION, SOLUTION | 4 | | 2 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-963 | ACETYLCYSTEINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 13 | Current NDC, Legacy NDC, 2 package rows | 20221103_d990ef51-ced2-4359-b99b-092334d2dc9b.zip |
| 63323-963 | ACETYLCYSTEINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221103_8cca4e4c-85a2-d575-e053-2995a90a6599.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-963-21 | 63323096321 | 30 mL in 1 VIAL, SINGLE-DOSE | 30 ml | | | | | Historical |
| 63323-963-30 | 63323096330 | 4 VIAL, SINGLE-DOSE in 1 CARTON (63323-963-30) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-963-21) | | 2012-11-09 | 0000-00-00 | No | No | Current |
| 63323-963-41 | 63323096341 | 30 mL in 1 VIAL, SINGLE-DOSE | 30 ml | | | | | Historical |
| 63323-963-44 | 63323096344 | 4 VIAL, SINGLE-DOSE in 1 CARTON (63323-963-44) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-963-41) | | 2012-11-09 | 0000-00-00 | No | No | Current |