Acetylcysteine
- Product NDC
- 0143-9433
- 11-digit product format
- 001439433
- Labeler code
- 0143
- Product ID
- 0143-9433_9480cdc0-fbc4-411d-b0e8-3d7cf9e9ec7a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetylcysteine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA217182
- Marketing category
- ANDA
- Marketing start
- 2026-03-31
- 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 |
|---|
| 0143-9433-01 | Acetylcysteine | 30 mL in 1 VIAL | INJECTION, SOLUTION | 30 | | 1 |
| 0143-9433-04 | Acetylcysteine | 4 in 1 CARTON | INJECTION, SOLUTION | 4 | | 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 |
|---|
| 0143-9433-01 | 00143943301 | 30 mL in 1 VIAL | 30 ml | | | | Historical |
| 0143-9433-04 | 00143943304 | 4 VIAL in 1 CARTON (0143-9433-04) / 30 mL in 1 VIAL (0143-9433-01) | 4 vial | 2026-03-31 | No | No | Historical |