What is NDC 46708-484?

46708-484 is the product NDC for Doxycycline Hyclate, Doxycycline hyclate 200 mg/1 tablet, delayed release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Doxycycline Hyclate?

175 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Doxycycline Hyclate NDC 46708-484 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-484Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0484Add 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
46708-484-30	4670804843046708048430	30 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-484-30)Marketed from Oct 15, 2022
46708-484-31	4670804843146708048431	100 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-484-31)Marketed from Jan 4, 2022
46708-484-60	4670804846046708048460	60 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-484-60)Marketed from Jan 4, 2022
46708-484-71	4670804847146708048471	500 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-484-71)Marketed from Jan 4, 2022

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 — 200 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213075
Marketing start: Jan 4, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Tetracyclines (Chemical structure)
Identifiers: Product ID 46708-484_e1387662-e286-469d-b85f-60344918a17bSPL ID e1387662-e286-469d-b85f-60344918a17bSPL set ID 44ac5de1-c0c6-4d58-9a49-b2dae60ea921RxCUI 406524, 434018, 799048, 1423080UNII 19XTS3T51UUPC 0346708483609, 0346708482602, 0346708481605, 0346708484606
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

N446708048430 followed by a unit qualifier and the quantity

Package 46708-0484-30. 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 Apr 10, 2023.

Indications (excerpt from the label)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, doxycycline hyclate delayed-release 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. Doxycycline is a tetracycline-class antibacterial indicated in the following conditions or disease. Doxyc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-484

What is NDC 46708-484?: 46708-484 is the product NDC for Doxycycline Hyclate, Doxycycline hyclate 200 mg/1 tablet, delayed release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Doxycycline Hyclate.
What is the active ingredient?: Doxycycline hyclate.
Who is the labeler?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Doxycycline Hyclate?: 175 other product NDCs are listed under this name. See all Doxycycline Hyclate 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 Doxycycline Hyclate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	Unit Dose Solutions, Inc.	87441-029	87441-0029-01
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	Coupler LLC	67046-0135	67046-0135-03
Doxycycline Hyclate	Doxycycline hyclate 50 mg/1	TabletOral	Strides Pharma Science Limited	64380-225	64380-0225-01
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	TabletOral	Strides Pharma Science Limited	64380-226	64380-0226-02
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4658	70518-4658-00
Doxycycline Hyclate	Doxycycline hyclate 50 mg/1	CapsuleOral	Zhejiang Yongtai Pharmaceutical Co., Ltd	69434-016	69434-0016-0369434-0016-06
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	Zhejiang Yongtai Pharmaceutical Co., Ltd	69434-017	69434-0017-0369434-0017-06
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	TabletOral	REMEDYREPACK INC.	70518-4544	70518-4544-00
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	Macleods Pharmaceuticals Limited	33342-386	33342-0386-0833342-0386-1233342-0386-15
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-392	33342-0392-0533342-0392-0833342-0392-11+2 more

All 176 Doxycycline Hyclate NDCs

Other NDCs under ANDA 213075

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

FDA NDC Directory listings under ANDA 213075
Product	Strength	Form · route	Labeler	Product NDC
Doxycycline Hyclate	Doxycycline hyclate 75 mg/1	Tablet, Delayed releaseOral	Alembic Pharmaceuticals Limited	46708-481
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	Tablet, Delayed releaseOral	Alembic Pharmaceuticals Limited	46708-482
Doxycycline Hyclate	Doxycycline hyclate 150 mg/1	Tablet, Delayed releaseOral	Alembic Pharmaceuticals Limited	46708-483
Doxycycline Hyclate	Doxycycline hyclate 75 mg/1	Tablet, Delayed releaseOral	Alembic Pharmaceuticals Inc.	62332-481
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	Tablet, Delayed releaseOral	Alembic Pharmaceuticals Inc.	62332-482
Doxycycline Hyclate	Doxycycline hyclate 150 mg/1	Tablet, Delayed releaseOral	Alembic Pharmaceuticals Inc.	62332-483
Doxycycline Hyclate	Doxycycline hyclate 200 mg/1	Tablet, Delayed releaseOral	Alembic Pharmaceuticals Inc.	62332-484