Acetylcysteine
- Product NDC
- 55150-259
- 11-digit product format
- 551500259
- Labeler code
- 55150
- Product ID
- 55150-259_74f2798c-0d88-4888-ad41-23e3d7111748
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetylcysteine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA207358
- Marketing category
- ANDA
- Marketing start
- 2016-02-29
- Substance
- ACETYLCYSTEINE
- Active strength
- 6 g/30mL
- 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 | 6 g/30mL |
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 |
|---|
| 55150-259-30 | Acetylcysteine | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | | 6 |
| 55150-259-30 | 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 |
|---|
| 55150-259 | ACETYLCYSTEINE INJECTION, SOLUTION [EUGIA US LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230804_5ae53725-1abb-4122-9c85-f26c2c31566c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55150-259-30 | 55150025930 | 4 VIAL, SINGLE-DOSE in 1 CARTON (55150-259-30) / 30 mL in 1 VIAL, SINGLE-DOSE | 2016-02-29 | 0000-00-00 | No | No | Current |