Prescription drug · ANDA
Alcaine (Proparacaine hydrochloride) NDC 0998-0016
Proparacaine hydrochloride 5 mg/mL · Solution/ drops · Ophthalmic · Alcon Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0998-0016-15 | 00998001615 | 1 BOTTLE in 1 CARTON (0998-0016-15) / 15 mL in 1 BOTTLEMarketed from Oct 19, 1973 |
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)
- Alcaine
- Generic name (nonproprietary)
- proparacaine hydrochloride
- Active ingredients
- Proparacaine hydrochloride — 5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Alcon Laboratories, Inc.NDC labeler code 0998
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080027
- Marketing start
- Listing expires
- Other FDA classes
- Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0998-0016_2060dc26-3548-4b86-900c-ef53b5f453a2SPL ID 2060dc26-3548-4b86-900c-ef53b5f453a2SPL set ID 0c0fa0bf-977d-4539-b8dc-54c187c5b094RxCUI 1191013, 1191026UNII U96OL57GOY
- Pharmacologic class
- 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
N400998001615followed by a unit qualifier and the quantityPackage 00998-0016-15. 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: ALCAINE™ ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures.
Excerpt only. Read the full label for complete information.
About NDC 0998-0016
- What is NDC 0998-0016?
- 0998-0016 is the product NDC for Alcaine (proparacaine hydrochloride), Proparacaine hydrochloride 5 mg/mL solution/ drops, listed with the FDA by Alcon Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alcaine (Proparacaine hydrochloride).
- What is the active ingredient?
- Proparacaine hydrochloride.
- Who is the labeler?
- Alcon Laboratories, Inc., NDC labeler code 0998. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alcaine?
- 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.
Other NDCs under ANDA 080027
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Sandoz Inc. | 61314-016 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Sportpharm LLC | 85766-056 |
| proparacaine hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-5139 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | REMEDYREPACK INC. | 70518-3408 |