Doxycycline Hyclate NDC 46708-387

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-387Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0387Add 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
46708-387-60	46708038760	60 TABLET, FILM COATED in 1 BOTTLE (46708-387-60)Marketed from Jun 30, 2020
46708-387-91	46708038791	1000 TABLET, FILM COATED in 1 BOTTLE (46708-387-91)Marketed from Jun 30, 2020

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 — 75 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211744
Marketing start: Jun 30, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Tetracyclines (Chemical structure)
Identifiers: Product ID 46708-387_8becf01f-63de-4cf3-881e-94d18fe9274cSPL ID 8becf01f-63de-4cf3-881e-94d18fe9274cSPL set ID 6e587d8d-1a82-4dfa-acea-88704d408f2fRxCUI 1649425, 1650446UNII 19XTS3T51UUPC 0346708387600
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

N446708038760 followed by a unit qualifier and the quantity

Package 46708-0387-60. 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, 2023.

Indications (excerpt from the label)

Doxycycline hyclate tablets 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 doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211744

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

FDA NDC Directory listings under ANDA 211744
Product	Strength	Form · route	Labeler	Product NDC
Doxycycline Hyclate	Doxycycline hyclate 150 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-388
Doxycycline Hyclate	Doxycycline hyclate 75 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-387
Doxycycline Hyclate	Doxycycline hyclate 150 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-388