Prescription drug · ANDA
Isoflurane, (Volatile for Inhalation) (Isoflurane) NDC 83301-0072
Isoflurane 250 mL/250mL · Liquid · Respiratory (Inhalation) · Mullan Pharmaceutical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83301-0072-2 | 8330100720283301007202 | 6 BOTTLE, GLASS in 1 CASE (83301-0072-2) / 250 mL in 1 BOTTLE, GLASS (83301-0072-1)Marketed from Apr 1, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Isoflurane, (Volatile for Inhalation)
- Generic name (nonproprietary)
- isoflurane
- Active ingredients
- Isoflurane — 250 mL/250mL
- Dosage form
- Liquid
- Route
- Respiratory (Inhalation)
- Labeler
- Mullan Pharmaceutical Inc.NDC labeler code 83301
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216527
- Marketing start
- Listing expires
- Other FDA classes
- General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 83301-0072_785ebf29-1bf1-4efa-8c59-a4a41be9b7f2SPL ID 785ebf29-1bf1-4efa-8c59-a4a41be9b7f2SPL set ID 525a2467-548d-4b10-b181-91b90e99ae1bRxCUI 542347UNII CYS9AKD70PUPC 0383301007115, 0383301007214
- 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
N483301007202followed by a unit qualifier and the quantityPackage 83301-0072-02. 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)
1. INDICATIONS AND USAGE Isoflurane, USP liquid for inhalation may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia. Isoflurane, USP liquid for inhalation, a general anesthetic, is an inhalation agent indicated for induction and maintenance of general anesthesia. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 83301-0072
- What is NDC 83301-0072?
- 83301-0072 is the product NDC for Isoflurane, (Volatile for Inhalation), Isoflurane 250 mL/250mL liquid, listed with the FDA by Mullan Pharmaceutical Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Isoflurane, (Volatile for Inhalation) (Isoflurane).
- What is the active ingredient?
- Isoflurane.
- Who is the labeler?
- Mullan Pharmaceutical Inc., NDC labeler code 83301. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Isoflurane, (Volatile for Inhalation)?
- 1 other product NDC are listed under this name. See all Isoflurane, (Volatile for Inhalation) NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Isoflurane, (Volatile for Inhalation) products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Isoflurane, (Volatile for Inhalation)isoflurane | Isoflurane 100 mL/100mL | LiquidRespiratory (Inhalation) | Mullan Pharmaceutical Inc. | 83301-0071 | 83301-0071-02 |
Other NDCs under ANDA 216527
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 |
|---|---|---|---|---|
| Isoflurane | Isoflurane 100 mL/100mL | LiquidRespiratory (Inhalation) | Shandong New Time Pharmaceutical Co., Ltd. | 42677-326 |
| Isoflurane | Isoflurane 250 mL/250mL | LiquidRespiratory (Inhalation) | Shandong New Time Pharmaceutical Co., Ltd. | 42677-327 |
| Isoflurane, (Volatile for Inhalation)isoflurane | Isoflurane 100 mL/100mL | LiquidRespiratory (Inhalation) | Mullan Pharmaceutical Inc. | 83301-0071 |