What is NDC 61919-106?

61919-106 is the product NDC for gentamicin sulfate, Gentamicin sulfate 3 mg/mL solution/ drops, listed with the FDA by DIRECT RX. It has 1 package NDC, shown above in 10- and 11-digit form.

DIRECT RX, NDC labeler code 61919. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for gentamicin sulfate?

25 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

gentamicin sulfate NDC 61919-106 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61919-106Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61919-0106Add 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
61919-106-05	6191901060561919010605	5 mL in 1 CARTON (61919-106-05)Marketed from May 7, 2015

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): gentamicin sulfate
Generic name (nonproprietary): gentamicin sulfate
Active ingredients: Gentamicin sulfate — 3 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: DIRECT RXNDC labeler code 61919
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 062452
Marketing start: Jan 1, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 61919-106_0e997972-7ec7-5a7a-e063-6294a90aceacSPL ID 0e997972-7ec7-5a7a-e063-6294a90aceacSPL set ID 51a411a0-2671-4c1c-bf25-e29b32efed0cRxCUI 310467UNII 8X7386QRLV
Pharmacologic class: Aminoglycoside Antibacterial

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

N461919010605 followed by a unit qualifier and the quantity

Package 61919-0106-05. 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 Jan 10, 2024.

Indications (excerpt from the label)

INDICATIONS & USAGE SECTION Gentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61919-106

What is NDC 61919-106?: 61919-106 is the product NDC for gentamicin sulfate, Gentamicin sulfate 3 mg/mL solution/ drops, listed with the FDA by DIRECT RX. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: gentamicin sulfate.
What is the active ingredient?: Gentamicin sulfate.
Who is the labeler?: DIRECT RX, NDC labeler code 61919. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for gentamicin sulfate?: 25 other product NDCs are listed under this name. See all gentamicin sulfate 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 gentamicin sulfate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Gentamicin Sulfate	Gentamicin sulfate 1 mg/g	OintmentTopical	Encube Ethicals, Inc.	21922-110	21922-0110-0421922-0110-05
Gentamicin Sulfate	Gentamicin sulfate 3 mg/mL	Solution/ dropsOphthalmic	Preferred Pharmaceuticals Inc.	68788-8592	68788-8592-05
Gentamicin Sulfate	Gentamicin sulfate 40 mg/mL	Injection, SolutionIntramuscular, Intravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1597	51662-1597-03
Gentamicin Sulfate	Gentamicin sulfate 40 mg/mL	Injection, SolutionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9865	00404-9865-02
Gentamicin Sulfate	Gentamicin sulfate 1 mg/g	CreamTopical	Cosette Pharmaceuticals, Inc.	0713-0683	00713-0683-1500713-0683-31
Gentamicin Sulfate	Gentamicin sulfate 40 mg/mL	Injection, SolutionIntramuscular, Intravenous	Medical Purchasing Solutions, LLC	71872-7216	71872-7216-01
Gentamicin Sulfate	Gentamicin sulfate 1 mg/g	OintmentTopical	Cosette Pharmaceuticals, Inc.	0713-0682	00713-0682-1500713-0682-31
Gentamicin Sulfate	Gentamicin sulfate 1 mg/g	OintmentTopical	Proficient Rx LP	71205-560	71205-0560-15
Gentamicin Sulfate	Gentamicin sulfate 3 mg/mL	Solution/ dropsOphthalmic	Proficient Rx LP	63187-764	63187-0764-05
Gentamicin Sulfate	Gentamicin sulfate 3 mg/mL	Solution/ dropsOphthalmic	NuCare Pharmaceuticals, Inc.	66267-971	66267-0971-05

All 26 gentamicin sulfate NDCs

Other NDCs under ANDA 062452

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

FDA NDC Directory listings under ANDA 062452
Product	Strength	Form · route	Labeler	Product NDC
Gentamicin Sulfate	Gentamicin sulfate 3 mg/mL	Solution/ dropsOphthalmic	NuCare Pharmaceuticals,Inc.	68071-4827