NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0245Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0245Add 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 NDC11-digit (billing)PackageCopy
80425-0245-180425024501804250245011 KIT in 1 CARTON (80425-0245-1) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 10 AMPULE in 1 CARTON (55150-158-72) / 2 mL in 1 AMPULE * 1 mL in 1 VIAL, SINGLE-DOSE (72611-722-01)Marketed from May 12, 2023

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)
Ketorocaine LM Kit
Generic name (nonproprietary)
ketorolac tromethamine, lidocaine hydrochloride, bupivacaine hydrochloride, povidine iodine
Dosage form
Kit
Route
Epidural, Infiltration, Intramuscular, Intravenous, Topical
Labeler
Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Identifiers
Product ID 80425-0245_2a9ad9e4-1651-c0dc-e063-6294a90a6e45SPL ID 2a9ad9e4-1651-c0dc-e063-6294a90a6e45SPL set ID fb81d452-30e0-f019-e053-6394a90a7634RxCUI 797544, 797730, 1665461, 1725078, 1725082, 1737568

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

N480425024501 followed by a unit qualifier and the quantity

Package 80425-0245-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Bupivacaine Hydrochloride Injection contains bupivacaine, an amide local anesthetic. Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. ( 1, 2.2) Limitations of Use Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection given clinically significant risks associated with use. ( 1, 2.2, 4, 5.1, 5.4, 5.5, 5.7, 5.9) Bupivacaine Hydrochloride…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0245

What is NDC 80425-0245?
80425-0245 is the product NDC for Ketorocaine LM Kit kit, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ketorocaine LM Kit (Ketorolac Tromethamine, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine).
Who is the labeler?
Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ketorocaine LM Kit?
1 other product NDC are listed under this name. See all Ketorocaine LM Kit 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 Ketorocaine LM Kit NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ketorocaine LM Kitketorolac tromethamine, lidocaine hydrochloride, bupivacaine hydrochloride, povidine iodine—KitEpidural, Infiltration, Intramuscular, Intravenous, TopicalAsclemed USA, Inc.76420-77276420-0772-01

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