NDC codes

FDA NDC Directory
Product NDC (as listed)0078-0729Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00078-0729Add 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
0078-0729-1000078072910000780729101 BOTTLE in 1 CARTON (0078-0729-10) / 10 mL in 1 BOTTLEMarketed from Aug 3, 2022
0078-0729-1500078072915000780729151 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
Labeler
Novartis Pharmaceuticals CorporationNDC labeler code 0078
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

N400078072910 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 0078-0729

What is NDC 0078-0729?
0078-0729 is the product NDC for Betoptic S (betaxolol hydrochloride), Betaxolol hydrochloride 2.8 mg/mL suspension/ drops, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Betoptic S (Betaxolol hydrochloride).
What is the active ingredient?
Betaxolol hydrochloride.
Who is the labeler?
Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Betoptic S?
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.

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