Acetylcysteine
- Product NDC
- 63323-695
- 11-digit product format
- 633230695
- Labeler code
- 63323
- Product ID
- 63323-695_da00a3b4-d7e8-464b-a13f-422b445de8ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ACETYLCYSTEINE
- Dosage form
- SOLUTION
- Route
- ORAL; RESPIRATORY (INHALATION)
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA204674
- Marketing category
- ANDA
- Marketing start
- 2014-03-31
- Substance
- ACETYLCYSTEINE
- Active strength
- 100 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 | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WYQ7N0BPYC |
| Rxcui | 307718, 307719 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-695-04 | Acetylcysteine | 25 in 1 CARTON | SOLUTION | 25 | | 11 |
| 63323-695-22 | Acetylcysteine | 4 mL in 1 VIAL | SOLUTION | 4 | | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-695 | ACETYLCYSTEINE SOLUTION [FRESENIUS KABI USA, LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240823_75b48fab-cef6-465c-a1e0-d085b3988bc4.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 |
|---|
| 63323-695-04 | 63323069504 | 25 VIAL in 1 CARTON (63323-695-04) / 4 mL in 1 VIAL (63323-695-22) | 25 vial | 2014-03-31 | 0000-00-00 | No | No | Current |
| 63323-695-22 | 63323069522 | 4 mL in 1 VIAL | 4 ml | | | | | Historical |