Prescription drug · NDA
Betoptic S (betaxolol hydrochloride) NDC 0078-0729
Betaxolol hydrochloride 2.8 mg/mL · Suspension/ drops · Ophthalmic · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0729-10 | 00078072910 | 1 BOTTLE in 1 CARTON (0078-0729-10) / 10 mL in 1 BOTTLEMarketed from Aug 3, 2022 | |
| 0078-0729-15 | 00078072915 | 1 BOTTLE in 1 CARTON (0078-0729-15) / 15 mL in 1 BOTTLEMarketed from Aug 3, 2022 |
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)
- Betoptic S
- Generic name (nonproprietary)
- betaxolol hydrochloride
- Active ingredients
- Betaxolol hydrochloride — 2.8 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019845
- Marketing start
- Marketing end
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 0078-0729_c0cc485e-81d4-4204-a894-caa615bea90bSPL ID c0cc485e-81d4-4204-a894-caa615bea90bSPL set ID 905ba189-456c-4aa4-8231-39a971374ad8RxCUI 213729, 308719UNII 6X97D2XT0O
- Pharmacologic class
- beta-Adrenergic Blocker
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
N400078072910followed by a unit qualifier and the quantityPackage 00078-0729-10. 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)
BETOPTIC S ® (betaxolol hydrochloride ophthalmic suspension) 0.25% is indicated for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension. BETOPTIC S is a beta-adrenergic receptor inhibitor indicated for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension. ( 1 )
Excerpt only. Read the full label for complete information.