Doxycycline Hyclate NDC 43386-794

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-794Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0794Add 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
43386-794-01	43386079401	100 TABLET in 1 BOTTLE (43386-794-01)Marketed from Sep 6, 2017
43386-794-05	43386079405	500 TABLET in 1 BOTTLE (43386-794-05)Marketed from Sep 6, 2017
43386-794-50	43386079450	50 TABLET in 1 BOTTLE (43386-794-50)Marketed from Sep 6, 2017

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): Doxycycline Hyclate
Generic name (nonproprietary): doxycycline hyclate
Active ingredients: Doxycycline hyclate — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Lupin Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207558
Marketing start: Sep 6, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Tetracyclines (Chemical structure)
Identifiers: Product ID 43386-794_21feab96-ff6a-4924-8dcb-becaf40d9356SPL ID 21feab96-ff6a-4924-8dcb-becaf40d9356SPL set ID b752ea66-3144-4f78-96fe-a5f4d92740a7RxCUI 1650143UNII 19XTS3T51UUPC 0343386794508, 0343386794027, 0343386794102, 0343386794010
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

N443386079401 followed by a unit qualifier and the quantity

Package 43386-0794-01. 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 Jan 30, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP 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 is indicated for the treatment of the following infections: Rocky Mountain spotted fev…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207558

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

FDA NDC Directory listings under ANDA 207558
Product	Strength	Form · route	Labeler	Product NDC
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	TabletOral	Novel Laboratories, Inc.	40032-794