Prescription drug · ANDA
Proparacaine Hydrochloride NDC 68071-4368
Proparacaine hydrochloride 5 mg/mL · Solution/ drops · Ophthalmic · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4368-5 | 6807143680568071436805 | 15 mL in 1 BOX (68071-4368-5)Marketed from Mar 30, 2018 |
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)
- Proparacaine Hydrochloride
- Generic name (nonproprietary)
- proparacaine hydrochloride
- Active ingredients
- Proparacaine hydrochloride — 5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040074
- Marketing start
- Listing expires
- Other FDA classes
- Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 68071-4368_1a555cda-0c40-ba30-e063-6394a90a3525SPL ID 1a555cda-0c40-ba30-e063-6394a90a3525SPL set ID 68a84d3f-a8f8-13ee-e053-2991aa0a7592RxCUI 1191013UNII U96OL57GOYUPC 0368071436853
- 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
N468071436805followed by a unit qualifier and the quantityPackage 68071-4368-05. 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)
INDICATIONS AND USAGE Proparacaine hydrochloride 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 68071-4368
- What is NDC 68071-4368?
- 68071-4368 is the product NDC for Proparacaine Hydrochloride, Proparacaine hydrochloride 5 mg/mL solution/ drops, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Proparacaine Hydrochloride.
- What is the active ingredient?
- Proparacaine hydrochloride.
- Who is the labeler?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Proparacaine Hydrochloride?
- 11 other product NDCs are listed under this name. See all Proparacaine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Proparacaine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Proparacaine hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Micro Labs Limited | 42571-497 | 42571-0497-57 |
| Proparacaine hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Lifestar Pharma LLC | 70756-193 | 70756-0193-35 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-601 | 70069-0601-01 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Sportpharm LLC | 85766-039 | 85766-0039-15 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | REMEDYREPACK INC. | 70518-3408 | 70518-3408-00 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Sandoz Inc. | 61314-016 | 61314-0016-01 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Sportpharm LLC | 85766-056 | 85766-0056-15 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-730 | 24208-0730-06 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-1923 | 50090-1923-00 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Sportpharm LLC | 85766-057 | 85766-0057-15 |
Other NDCs under ANDA 040074
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 | Bausch & Lomb Incorporated | 24208-730 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-1923 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Sportpharm LLC | 85766-057 |