What is NDC 70069-517?

70069-517 is the product NDC for Timolol hemihydrate, Timolol maleate 5 mg/mL solution/ drops, listed with the FDA by Somerset Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Somerset Therapeutics, LLC, NDC labeler code 70069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Timolol hemihydrate?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Timolol hemihydrate NDC 70069-517 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70069-517Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70069-0517Add 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 NDC	11-digit (billing)	Package	Copy
70069-517-01	7006905170170069051701	1 BOTTLE in 1 CARTON (70069-517-01) / 5 mL in 1 BOTTLEMarketed from Jul 9, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Timolol hemihydrate
Generic name (nonproprietary): timolol hemihydrate
Active ingredients: Timolol maleate — 5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Somerset Therapeutics, LLCNDC labeler code 70069
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216653
Marketing start: Jul 9, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 70069-517_71408752-090e-4566-9cdf-7e0074200d3aSPL ID 71408752-090e-4566-9cdf-7e0074200d3aSPL set ID bfd95433-e47a-4c5c-9bdf-77bffc13544dRxCUI 1992299UNII P8Y54F701RUPC 0370069517017, 0370069516010
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

N470069051701 followed by a unit qualifier and the quantity

Package 70069-0517-01. 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 Jul 10, 2024.

Indications (excerpt from the label)

Timolol maleate ophthalmic solution 0.5% is a non-selective beta-adrenergic receptor blocking agent indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. Timolol maleate ophthalmic solution is a non-selective beta-adrenergic receptor blocking agent indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70069-517

What is NDC 70069-517?: 70069-517 is the product NDC for Timolol hemihydrate, Timolol maleate 5 mg/mL solution/ drops, listed with the FDA by Somerset Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Timolol hemihydrate.
What is the active ingredient?: Timolol maleate.
Who is the labeler?: Somerset Therapeutics, LLC, NDC labeler code 70069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Timolol hemihydrate?: 4 other product NDCs are listed under this name. See all Timolol hemihydrate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Timolol hemihydrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Timolol Hemihydrate	Timolol anhydrous 5 mg/mL	Solution/ dropsOphthalmic	Somerset Therapeutics, LLC	70069-696	70069-0696-01
Timolol Hemihydrate	Timolol anhydrous 5 mg/mL	Solution/ dropsOphthalmic	Somerset Therapeutics, LLC	70069-697	70069-0697-01
Timolol Hemihydrate	Timolol anhydrous 5 mg/mL	Solution/ dropsOphthalmic	Somerset Therapeutics, LLC	70069-698	70069-0698-01
Timolol hemihydrate	Timolol maleate 5 mg/mL	Solution/ dropsOphthalmic	Somerset Therapeutics, LLC	70069-516	70069-0516-01

Other NDCs under ANDA 216653

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

FDA NDC Directory listings under ANDA 216653
Product	Strength	Form · route	Labeler	Product NDC
Timolol hemihydrate	Timolol maleate 5 mg/mL	Solution/ dropsOphthalmic	Somerset Therapeutics, LLC	70069-516