What is NDC 16110-601?

16110-601 is the product NDC for Acticlate CAP (doxycycline hyclate), Doxycycline hyclate 75 mg/1 capsule, listed with the FDA by Aqua Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Acticlate CAP (Doxycycline hyclate).

Aqua Pharmaceuticals, NDC labeler code 16110. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Acticlate CAP?

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.

Acticlate CAP NDC 16110-601 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16110-601Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16110-0601Add 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
16110-601-01	1611006010116110060101	60 CAPSULE in 1 BOTTLE (16110-601-01)Marketed from May 31, 2018

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): Acticlate CAPSuffix: CAP
Generic name (nonproprietary): doxycycline hyclate
Active ingredients: Doxycycline hyclate — 75 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Aqua PharmaceuticalsNDC labeler code 16110
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208253
Marketing start: May 31, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Tetracyclines (Chemical structure)
Identifiers: Product ID 16110-601_2e463b1b-d30e-4ae6-95c3-853aba0221a4SPL ID 2e463b1b-d30e-4ae6-95c3-853aba0221a4SPL set ID 5e96d473-63dd-4446-88cf-eef2cd3339f0RxCUI 1791505, 1791507UNII 19XTS3T51UUPC 0316110601014
Pharmacologic class: Tetracycline-class Drug

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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N416110060101 followed by a unit qualifier and the quantity

Package 16110-0601-01. 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 Nov 28, 2017.

Indications (excerpt from the label)

ACTICLATE ® and ACTICLATE ® CAP are tetracycline class drugs indicated for: Rickettsial infections ( 1.1 ) Sexually transmitted infections ( 1.2 ) Respiratory tract infections ( 1.3 ) Specific bacterial infections ( 1.4 ) Ophthalmic infections ( 1.5 ) Anthrax, including inhalational anthrax (post-exposure) ( 1.6 ) Alternative treatment for selected infections when penicillin is contraindicated ( 1.7 ) Adjunctive therapy for acute intestinal amebiasis and severe acne ( 1.8 ) Prophylaxis of malaria ( 1.9 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of ACTICLATE and ACTICLATE CAP and other antibacterial drugs, ACTICLATE and ACTICLATE CAP should be used o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16110-601

What is NDC 16110-601?: 16110-601 is the product NDC for Acticlate CAP (doxycycline hyclate), Doxycycline hyclate 75 mg/1 capsule, listed with the FDA by Aqua Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Acticlate CAP (Doxycycline hyclate).
What is the active ingredient?: Doxycycline hyclate.
Who is the labeler?: Aqua Pharmaceuticals, NDC labeler code 16110. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acticlate CAP?: 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.

Other NDCs under NDA 208253

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

FDA NDC Directory listings under NDA 208253
Product	Strength	Form · route	Labeler	Product NDC
Doxycycline Hyclate	Doxycycline hyclate 75 mg/1	CapsuleOral	Chartwell RX, LLC	62135-975

Acticlate CAP (Doxycycline hyclate) NDC 16110-601