Acetylcysteine
- Product NDC
- 0409-3307
- 11-digit product format
- 004093307
- Labeler code
- 0409
- Product ID
- 0409-3307_6c12470d-0f1a-4085-938d-121df34c3cb0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ACETYLCYSTEINE
- Dosage form
- SOLUTION
- Route
- ORAL; RESPIRATORY (INHALATION)
- Labeler
- Hospira, Inc.
- Application
- ANDA073664
- Marketing category
- ANDA
- Marketing start
- 2005-04-30
- Substance
- ACETYLCYSTEINE
- Active strength
- 100 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 | 100 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 |
|---|
| 0409-3307-03 | Acetylcysteine | 3 in 1 CARTON | SOLUTION | 3 | | 22 |
| 0409-3307-11 | Acetylcysteine | 30 mL in 1 VIAL | SOLUTION | 30 | | 22 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-3307 | ACETYLCYSTEINE SOLUTION [HOSPIRA, INC.] | 20 | Current NDC, Legacy NDC, 2 package rows | 20241018_5558a5f5-e821-473b-7d8a-5d33d09f0586.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 |
|---|
| 0409-3307-03 | 00409330703 | 3 VIAL in 1 CARTON (0409-3307-03) / 30 mL in 1 VIAL (0409-3307-11) | 3 vial | 2005-04-30 | 0000-00-00 | No | No | Current |
| 0409-3307-11 | 00409330711 | 30 mL in 1 VIAL | 30 ml | | | | | Historical |