NDC codes

FDA NDC Directory
Product NDC (as listed)54288-127Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54288-0127Add 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
54288-127-10542880127105428801271010 VIAL in 1 BOX (54288-127-10) / 2 mL in 1 VIAL (54288-127-01)Marketed from Jun 26, 2020

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)
Tetracaine HCL
Generic name (nonproprietary)
tetracaine hcl
Active ingredients
Tetracaine hydrochloride — 10 mg/mL
Dosage form
Injection
Route
Subarachnoid
Labeler
BPI LABS LLCNDC labeler code 54288
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Other FDA classes
Esters (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 54288-127_df1a3d1f-8d9c-4ae6-9cad-527680105425SPL ID df1a3d1f-8d9c-4ae6-9cad-527680105425SPL set ID 2b3349c1-bd02-4442-9bf0-40a654bb8a80RxCUI 198248UNII 5NF5D4OPCIUPC 0354288127103
Pharmacologic class
Ester Local 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

N454288012710 followed by a unit qualifier and the quantity

Package 54288-0127-10. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE: Tetracaine hydrochloride is indicated for the production of spinal anesthesia for procedures requiring two to three hours.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54288-127

What is NDC 54288-127?
54288-127 is the product NDC for Tetracaine HCL, Tetracaine hydrochloride 10 mg/mL injection, listed with the FDA by BPI LABS LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tetracaine HCL.
What is the active ingredient?
Tetracaine hydrochloride.
Who is the labeler?
BPI LABS LLC, NDC labeler code 54288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tetracaine HCL?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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