Prescription drug · ANDA
Telmisartan and Hydrochlorothiazide NDC 46708-211
Telmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-211-10 | 46708021110 | 100 TABLET in 1 CARTON (46708-211-10)Marketed from Mar 14, 2014 | |
| 46708-211-30 | 46708021130 | 30 TABLET in 1 BOTTLE (46708-211-30)Marketed from Mar 14, 2014 | |
| 46708-211-91 | 46708021191 | 1000 TABLET in 1 BOTTLE (46708-211-91)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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203010
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 46708-211_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
N446708021110followed by a unit qualifier and the quantityPackage 46708-0211-10. 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 . 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.