acetylcysteine
- Product NDC
- 0574-0805
- 11-digit product format
- 005740805
- Labeler code
- 0574
- Product ID
- 0574-0805_b123834f-a908-4e77-bf87-32dffefa20f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetylcysteine
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Padagis US LLC
- Application
- NDA021539
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-12-20
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- acetylcysteine
- Listing expiration
- 2027-12-31
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 |
|---|
| 0574-0805-30 | acetylcysteine | 30 mL in 1 VIAL | INJECTION | 30 | | 12 |
| 0574-0805-30 | acetylcysteine | 4 in 1 CARTON | INJECTION | 4 | | 12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0574-0805 | ACETYLCYSTEINE INJECTION [PADAGIS US LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20241101_9d305722-e74f-4f48-8d2c-0daa99144749.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 |
|---|
| 0574-0805-30 | 00574080530 | 4 VIAL in 1 CARTON (0574-0805-30) / 30 mL in 1 VIAL | 4 vial | 2012-12-20 | 0000-00-00 | No | No | Current |