ACETYLCYSTEINE
- Product NDC
- 14445-412
- 11-digit product format
- 144450412
- Labeler code
- 14445
- Product ID
- 14445-412_2b8da336-9b90-466e-9ac2-6f6cbb999f9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ACETYLCYSTEINE
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Indoco Remedies Limited
- Application
- ANDA215620
- Marketing category
- ANDA
- Marketing start
- 2022-03-01
- 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 |
|---|
| 14445-412-04 | ACETYLCYSTEINE | 4 in 1 CARTON | INJECTION | 4 | | 4 |
| 14445-412-30 | ACETYLCYSTEINE | 30 mL in 1 VIAL | INJECTION | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 14445-412 | ACETYLCYSTEINE INJECTION [INDOCO REMEDIES LIMITED ] | 4 | Current NDC, Legacy NDC, 2 package rows | 20220302_6588c28d-0515-4cdf-99d3-c4ad3fd0976c.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 |
|---|
| 14445-412-04 | 14445041204 | 4 VIAL in 1 CARTON (14445-412-04) / 30 mL in 1 VIAL (14445-412-30) | 4 vial | 2022-03-01 | 0000-00-00 | No | No | Current |
| 14445-412-30 | 14445041230 | 30 mL in 1 VIAL | 30 ml | | | | | Historical |