Telmisartan and Hydrochlorothiazide NDC 46708-210

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-210Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0210Add 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
46708-210-10	46708021010	100 TABLET in 1 CARTON (46708-210-10)Marketed from Mar 14, 2014
46708-210-30	46708021030	30 TABLET in 1 BOTTLE (46708-210-30)Marketed from Mar 14, 2014
46708-210-91	46708021091	1000 TABLET in 1 BOTTLE (46708-210-91)Marketed from Mar 14, 2014

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): Telmisartan and Hydrochlorothiazide
Generic name (nonproprietary): telmisartan and hydrochlorothiazide
Active ingredients: Telmisartan — 80 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203010
Marketing start: Mar 14, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 46708-210_7c37a82a-77c2-4d49-84ee-ee4f70b4ec93SPL ID 7c37a82a-77c2-4d49-84ee-ee4f70b4ec93SPL set ID 5b476740-e3f0-4f68-b07c-cd9eb2fa27caRxCUI 283316, 283317, 477130UNII 0J48LPH2TH, U5SYW473RQUPC 0346708211301, 0346708209308, 0346708210304
Pharmacologic class: Angiotensin 2 Receptor Blocker; Thiazide Diuretic

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

N446708021010 followed by a unit qualifier and the quantity

Package 46708-0210-10. 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 23, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & USAGE Telmisartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203010

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

FDA NDC Directory listings under ANDA 203010
Product	Strength	Form · route	Labeler	Product NDC
Telmisartan and Hydrochlorothiazide	Telmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-211
Telmisartan and Hydrochlorothiazide	Telmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-209
Telmisartan and Hydrochlorothiazide	Telmisartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-210
Telmisartan and Hydrochlorothiazide	Telmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-209
Telmisartan and Hydrochlorothiazide	Telmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-211