Acetylcysteine
- Product NDC
- 42494-436
- 11-digit product format
- 424940436
- Labeler code
- 42494
- Product ID
- 42494-436_a0973436-d684-4b3c-88ef-103e3005e6bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetylcysteine
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Cameron Pharmaceuticals
- Application
- ANDA214177
- Marketing category
- ANDA
- Marketing start
- 2025-08-21
- 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 | 307718, 307719 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42494-436-25 | Acetylcysteine | 4 mL in 1 VIAL | SOLUTION | 4 | | 1 |
| 42494-436-25 | Acetylcysteine | 25 in 1 CARTON | SOLUTION | 25 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42494-436-25 | 42494043625 | 25 VIAL in 1 CARTON (42494-436-25) / 4 mL in 1 VIAL | 25 vial | 2025-08-21 | No | No | Current |