Prescription drug · ANDA
Sevoflurane NDC 10019-653
Sevoflurane 250 mL/250mL · Liquid · Respiratory (Inhalation) · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10019-653-64 | 10019065364 | 6 BOTTLE in 1 CARTON (10019-653-64) / 250 mL in 1 BOTTLEMarketed from Jul 7, 2002 |
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)
- Sevoflurane
- Generic name (nonproprietary)
- sevoflurane
- Active ingredients
- Sevoflurane — 250 mL/250mL
- Dosage form
- Liquid
- Route
- Respiratory (Inhalation)
- Labeler
- Baxter Healthcare CorporationNDC labeler code 10019
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075895
- Marketing start
- Listing expires
- Other FDA classes
- General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 10019-653_e04090f9-97a3-4fe5-9bc1-c4a86ac9a6a1SPL ID e04090f9-97a3-4fe5-9bc1-c4a86ac9a6a1SPL set ID 22700993-851a-48aa-941e-1d2b6b04081fRxCUI 200243UNII 38LVP0K73A
- Pharmacologic class
- General Anesthetic
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.
- NDC on a medical claim
N410019065364followed by a unit qualifier and the quantityPackage 10019-0653-64. 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)
INDICATIONS AND USAGE Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Sevoflurane should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.
Excerpt only. Read the full label for complete information.
About NDC 10019-653
- What is NDC 10019-653?
- 10019-653 is the product NDC for Sevoflurane, Sevoflurane 250 mL/250mL liquid, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sevoflurane.
- What is the active ingredient?
- Sevoflurane.
- Who is the labeler?
- Baxter Healthcare Corporation, NDC labeler code 10019. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sevoflurane?
- 10 other product NDCs are listed under this name. See all Sevoflurane NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sevoflurane products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sevoflurane | Sevoflurane 250 mL/250mL | LiquidRespiratory (Inhalation) | Lannett Company, Inc. | 0527-6123 | 00527-6123-74 |
| Sevoflurane | Sevoflurane 250 mL/250mL | LiquidRespiratory (Inhalation) | Shandong New Time Pharmaceutical Co., Ltd. | 42677-308 | 42677-0308-01 |
| Sevoflurane | Sevoflurane 1 mL/mL | LiquidRespiratory (Inhalation) | Piramal Critical Care Inc | 66794-022 | 66794-0022-25 |
| Sevoflurane | Sevoflurane 250 mL/250mL | LiquidRespiratory (Inhalation) | Sandoz Inc. | 0781-6160 | 00781-6160-86 |
| Sevoflurane | Sevoflurane 1 mL/mL | LiquidRespiratory (Inhalation) | Piramal Critical Care Inc | 66794-015 | 66794-0015-25 |
| Sevoflurane | Sevoflurane 1 mL/mL | LiquidRespiratory (Inhalation) | Bryant Ranch Prepack | 72162-2245 | 72162-2245-02 |
| Sevoflurane | Sevoflurane 1 mL/mL | LiquidRespiratory (Inhalation) | Halocarbon Life Sciences, LLC | 12164-005 | 12164-0005-25 |
| Sevoflurane | Sevoflurane 250 mL/250mL | LiquidRespiratory (Inhalation) | Baxter Healthcare Corporation | 10019-657 | 10019-0657-06 |
| Sevoflurane | Sevoflurane 250 mL/250mL | LiquidRespiratory (Inhalation) | Baxter Healthcare Company | 10019-651 | 10019-0651-64 |
| Sevoflurane | Sevoflurane 250 mL/250mL | LiquidRespiratory (Inhalation) | Baxter Healthcare Company | 10019-655 | 10019-0655-06 |
Other NDCs under ANDA 075895
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sevoflurane | Sevoflurane 250 mL/250mL | LiquidRespiratory (Inhalation) | Baxter Healthcare Company | 10019-651 |
| Sevoflurane | Sevoflurane 250 mL/250mL | LiquidRespiratory (Inhalation) | Baxter Healthcare Company | 10019-655 |
| Sevoflurane | Sevoflurane 250 mL/250mL | LiquidRespiratory (Inhalation) | Baxter Healthcare Corporation | 10019-657 |