Acetylcysteine
- Product NDC
- 70069-788
- 11-digit product format
- 700690788
- Labeler code
- 70069
- Product ID
- 70069-788_d34802e0-7b94-49bd-b056-e28ad18e7418
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetylcysteine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA218397
- Marketing category
- ANDA
- Marketing start
- 2024-06-13
- 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 |
|---|
| 70069-788-04 | Acetylcysteine | 30 mL in 1 VIAL | INJECTION, SOLUTION | 30 | | 3 |
| 70069-788-04 | Acetylcysteine | 4 in 1 CARTON | INJECTION, SOLUTION | 4 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-788 | ACETYLCYSTEINE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC] | 3 | Current NDC, 2 package rows | 20240614_b8d3ed96-d7ee-43f4-986c-a7d04808711a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70069-788-04 | 70069078804 | 4 VIAL in 1 CARTON (70069-788-04) / 30 mL in 1 VIAL | 4 vial | 2024-06-13 | No | No | Current |