Acetylcysteine
- Product NDC
- 83270-001
- 11-digit product format
- 832700001
- Labeler code
- 83270
- Product ID
- 83270-001_3e98253c-4b61-85a5-e063-6394a90ab80c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetylcysteine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- ONESOURCE SPECIALTY PHARMA LIMITED
- Application
- ANDA217182
- Marketing category
- ANDA
- Marketing start
- 2023-04-26
- 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 |
|---|
| 83270-001-01 | Acetylcysteine | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | | 6 |
| 83270-001-04 | Acetylcysteine | 4 in 1 CARTON | INJECTION, SOLUTION | 4 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83270-001 | ACETYLCYSTEINE INJECTION, SOLUTION [ONESOURCE SPECIALTY PHARMA LIMITED] | 5 | Current NDC, 2 package rows | 20250523_3b0310d2-4e70-4b94-8d69-cb5999a32b54.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83270-001-01 | 83270000101 | 30 mL in 1 VIAL, SINGLE-DOSE | 30 ml | | | | Historical |
| 83270-001-04 | 83270000104 | 4 VIAL, SINGLE-DOSE in 1 CARTON (83270-001-04) / 30 mL in 1 VIAL, SINGLE-DOSE (83270-001-01) | | 2023-04-26 | No | No | Current |