Acetylcysteine
- Product NDC
- 25021-812
- 11-digit product format
- 250210812
- Labeler code
- 25021
- Product ID
- 25021-812_19a4f870-c3c9-4b28-bab4-3bb12156e602
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetylcysteine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA091684
- Marketing category
- ANDA
- Marketing start
- 2022-02-15
- 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 |
|---|
| 25021-812-30 | Acetylcysteine | 30 mL in 1 VIAL | INJECTION, SOLUTION | 30 | | 15 |
| 25021-812-30 | Acetylcysteine | 4 in 1 CARTON | INJECTION, SOLUTION | 4 | | 15 |
| 25021-812-66 | Acetylcysteine | 4 in 1 CARTON | INJECTION, SOLUTION | 4 | | 2 |
| 25021-812-66 | Acetylcysteine | 30 mL in 1 VIAL | INJECTION, SOLUTION | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-812 | ACETYLCYSTEINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 14 | Current NDC, Legacy NDC, 2 package rows | 20231115_c206c659-16ea-444a-8c60-8a3343400ada.zip |
| 25021-812 | ACETYLCYSTEINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230525_2324d60b-4f49-4759-a46e-a06bfce7e8aa.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 |
|---|
| 25021-812-30 | 25021081230 | 4 VIAL in 1 CARTON (25021-812-30) / 30 mL in 1 VIAL | 4 vial | 2018-04-15 | 0000-00-00 | No | No | Current |
| 25021-812-66 | 25021081266 | 4 VIAL in 1 CARTON (25021-812-66) / 30 mL in 1 VIAL | 4 vial | 2022-02-15 | 0000-00-00 | No | No | Current |