NDC codes

FDA NDC Directory
Product NDC (as listed)0187-0920Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00187-0920Add 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
0187-0920-05001870920051 BOTTLE in 1 CARTON (0187-0920-05) / 5 mL in 1 BOTTLEMarketed from Jun 27, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Hydrochloride
Generic name (nonproprietary)
tetracaine hydrochloride
Active ingredients
Tetracaine hydrochloride5 mg/mL
Dosage form
Solution/ drops
Route
Ophthalmic
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 210821
Marketing start
Marketing end
Other FDA classes
Esters (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 0187-0920_453da1ac-7306-7a40-e063-6394a90a741cSPL ID 453da1ac-7306-7a40-e063-6394a90a741cSPL set ID 78404c9e-9c31-4b0a-90f4-04182e82e183RxCUI 1547771UNII 5NF5D4OPCI
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 HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400187092005 followed by a unit qualifier and the quantity

Package 00187-0920-05. 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)

Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%, is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 210821

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

FDA NDC Directory listings under NDA 210821
ProductStrengthForm · routeLabelerProduct NDC
Tetracaine HydrochlorideTetracaine hydrochloride 5 mg/mLSolution/ dropsOphthalmicBausch & Lomb Incorporated24208-092
Tetracaine HydrochlorideTetracaine hydrochloride 5 mg/mLSolution/ dropsOphthalmicOceanside Pharmaceuticals68682-920
Tetracaine HydrochlorideTetracaine hydrochloride 5 mg/mLSolution/ dropsOphthalmicBausch & Lomb Americas Inc.82260-920

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