Doxycycline Hyclate NDC 0615-8529

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8529Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8529Add 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
0615-8529-14	00615852914	14 TABLET in 1 BLISTER PACK (0615-8529-14)Marketed from Sep 10, 2024

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): Doxycycline Hyclate
Generic name (nonproprietary): doxycycline hyclate
Active ingredients: Doxycycline hyclate — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207773
Marketing start: Mar 14, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Tetracyclines (Chemical structure)
Identifiers: Product ID 0615-8529_76fdd491-6791-487b-b3b3-fac23240d35aSPL ID 76fdd491-6791-487b-b3b3-fac23240d35aSPL set ID 104cac0f-7c99-4faf-ba08-0159ed767a3eRxCUI 1650143UNII 19XTS3T51U
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

N400615852914 followed by a unit qualifier and the quantity

Package 00615-8529-14. 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 Oct 7, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment Doxycycline hyclate tablets are indicated for the treatment of following infections: Rocky Mountain spotted f…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207773

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

FDA NDC Directory listings under ANDA 207773
Product	Strength	Form · route	Labeler	Product NDC
Doxycycline hyclate	Doxycycline hyclate 100 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1104
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-2113
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	TabletOral	RedPharm Drug, Inc.	67296-1431
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-001