What is NDC 43598-549?

43598-549 is the product NDC for Propofol Injectable Emulsion, Propofol 10 mg/mL injection, emulsion, listed with the FDA by Dr. Reddy's Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Dr. Reddy's Laboratories, Inc., NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Propofol Injectable Emulsion?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Propofol Injectable Emulsion NDC 43598-549

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-549Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0549Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
43598-549-10	4359805491043598054910	10 VIAL in 1 CARTON (43598-549-10) / 100 mL in 1 VIAL (43598-549-52)Marketed from Nov 15, 2018

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): Propofol Injectable Emulsion
Generic name (nonproprietary): propofol injectable emulsion
Active ingredients: Propofol — 10 mg/mL
Dosage form: Injection, Emulsion
Route: Intravenous
Labeler: Dr. Reddy's Laboratories, Inc.NDC labeler code 43598
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205067
Marketing start: Nov 15, 2018
Listing expires: Dec 31, 2026
Other FDA classes: General Anesthesia (Physiologic effect)
Identifiers: Product ID 43598-549_b4a9147e-dfe3-229a-d8d7-6a84e6449f15SPL ID b4a9147e-dfe3-229a-d8d7-6a84e6449f15SPL set ID 800646b8-83a8-01d9-3dc8-bb2ddcb8570cRxCUI 1808217, 1808222, 1808224UNII YI7VU623SF
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.

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.

How CPT relates to drug billing

NDC on a medical claim

N443598054910 followed by a unit qualifier and the quantity

Package 43598-0549-10. 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 Sep 30, 2022.

Indications (excerpt from the label)

Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: • Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age • Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age • Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients • Sedation for Adult Patients in Combination with Regional Anesthesia • Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients Limitations of Use Propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 m…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-549

What is NDC 43598-549?: 43598-549 is the product NDC for Propofol Injectable Emulsion, Propofol 10 mg/mL injection, emulsion, listed with the FDA by Dr. Reddy's Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Propofol Injectable Emulsion.
What is the active ingredient?: Propofol.
Who is the labeler?: Dr. Reddy's Laboratories, Inc., NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Propofol Injectable Emulsion?: 2 other product NDCs are listed under this name. See all Propofol Injectable Emulsion NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Propofol Injectable Emulsion NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Propofol Injectable Emulsion	Propofol 10 mg/mL	Injection, EmulsionIntravenous	Dr. Reddy's Laboratories, Inc.	43598-265	43598-0265-2543598-0265-58
Propofol Injectable Emulsion	Propofol 10 mg/mL	Injection, EmulsionIntravenous	Dr. Reddy's Laboratories, Inc.	43598-548	43598-0548-21

Other NDCs under ANDA 205067

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 205067
Product	Strength	Form · route	Labeler	Product NDC
Propofol Injectable Emulsion	Propofol 10 mg/mL	Injection, EmulsionIntravenous	Dr. Reddy's Laboratories, Inc.	43598-265
Propofol Injectable Emulsion	Propofol 10 mg/mL	Injection, EmulsionIntravenous	Dr. Reddy's Laboratories, Inc.	43598-548