Prescription drug · UNAPPROVED DRUG OTHER
Tetracaine HCL NDC 54288-127
Tetracaine hydrochloride 10 mg/mL · Injection · Subarachnoid · BPI LABS LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54288-127-10 | 5428801271054288012710 | 10 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
N454288012710followed by a unit qualifier and the quantityPackage 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.
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.