Prescription drug · ANDA
Acetylcysteine NDC 68462-946
Acetylcysteine 200 mg/mL · Injection, Solution · Intravenous · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-946-12 | 6846209461268462094612 | 4 VIAL, SINGLE-DOSE in 1 CARTON (68462-946-12) / 30 mL in 1 VIAL, SINGLE-DOSE (68462-946-30)Marketed from Sep 25, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Acetylcysteine
- Generic name (nonproprietary)
- acetylcysteine
- Active ingredients
- Acetylcysteine — 200 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213693
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Glutathione Concentration (Physiologic effect)Reduction Activity (Mechanism)
- Identifiers
- Product ID 68462-946_9a22e853-f45c-4bda-87e1-5aaf8e61a225SPL ID 9a22e853-f45c-4bda-87e1-5aaf8e61a225SPL set ID f811ddfc-d7c1-4637-ae81-80c38a77cb80RxCUI 465377UNII WYQ7N0BPYCUPC 0368462946305, 0368462946121
- Pharmacologic class
- Antidote; Antidote for Acetaminophen Overdose; Mucolytic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N468462094612followed by a unit qualifier and the quantityPackage 68462-0946-12. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Acetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with acute ingestion or from repeated supratherapeutic ingestion (RSI). Acetylcysteine Injection is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with an acute ingestion or from repeated supratherapeutic ingestion (RSI) ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 68462-946
- What is NDC 68462-946?
- 68462-946 is the product NDC for Acetylcysteine, Acetylcysteine 200 mg/mL injection, solution, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetylcysteine.
- What is the active ingredient?
- Acetylcysteine.
- Who is the labeler?
- Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acetylcysteine?
- 28 other product NDCs are listed under this name. See all Acetylcysteine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acetylcysteine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Acetylcysteine | Acetylcysteine 200 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9433 | 00143-9433-04 |
| Acetylcysteine | Acetylcysteine 100 mg/mL | SolutionRespiratory (Inhalation) | Cameron Pharmaceuticals | 42494-435 | 42494-0435-25 |
| Acetylcysteine | Acetylcysteine 200 mg/mL | SolutionRespiratory (Inhalation) | Cameron Pharmaceuticals | 42494-436 | 42494-0436-25 |
| Acetylcysteine | Acetylcysteine 100 mg/mL | SolutionRespiratory (Inhalation) | Somerset Therapeutics, LLC | 70069-018 | 70069-0018-25 |
| Acetylcysteine | Acetylcysteine 200 mg/mL | SolutionRespiratory (Inhalation) | Somerset Therapeutics, LLC | 70069-019 | 70069-0019-25 |
| Acetylcysteine | Acetylcysteine 200 mg/mL | SolutionRespiratory (Inhalation) | Somerset Therapeutics, LLC | 70069-020 | 70069-0020-03 |
| Acetylcysteine | Acetylcysteine 200 mg/mL | Injection, SolutionIntravenous | Somerset Therapeutics, LLC | 70069-788 | 70069-0788-04 |
| Acetylcysteine | Acetylcysteine 200 mg/mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-111 | 70594-0111-02 |
| Acetylcysteine | Acetylcysteine 200 mg/mL | Injection, SolutionIntravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-001 | 83270-0001-04 |
| Acetylcysteine | Acetylcysteine 200 mg/mL | InjectionIntravenous | Indoco Remedies Limited | 14445-412 | 14445-0412-04 |