Prescription drug · ANDA
Acetylcysteine NDC 63323-963
Acetylcysteine 200 mg/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-963-44 | 6332309634463323096344 | 4 VIAL, SINGLE-DOSE in 1 CARTON (63323-963-44) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-963-41)Marketed from Nov 9, 2012 |
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
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200644
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Glutathione Concentration (Physiologic effect)Reduction Activity (Mechanism)
- Identifiers
- Product ID 63323-963_2d292664-30db-4cb4-8e38-21b5d684c635SPL ID 2d292664-30db-4cb4-8e38-21b5d684c635SPL set ID 8cca4e4c-85a2-d575-e053-2995a90a6599RxCUI 465377UNII WYQ7N0BPYC
- 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
N463323096344followed by a unit qualifier and the quantityPackage 63323-0963-44. 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 an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen. Overdose incidences are divided into two types; Acute Ingestion or Repeated Supratherapeutic Ingestion (RSI). [see Dosage and Administration ( 2 ) and Acetaminophen Assays – Interpretation and Methodology -(Acute or Repeated Supratherapeutic Ingestion) ( 1.1 , 1.2 )] . On admission for suspected acetaminophen overdose, a serum blood sample should be drawn at least 4 hours after ingestion to determine the acetaminophen level and will serve as a basis for determining the need for treatment with acetylcysteine. I…
Excerpt only. Read the full label for complete information.
About NDC 63323-963
- What is NDC 63323-963?
- 63323-963 is the product NDC for Acetylcysteine, Acetylcysteine 200 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. 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?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. 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 | Glenmark Pharmaceuticals Inc., USA | 68462-946 | 68462-0946-12 |
| 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 |