Prescription drug · ANDA
Carvedilol NDC 55111-252
Carvedilol 3.125 mg/1 · Tablet, Film coated · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-252-01 | 55111025201 | 100 TABLET, FILM COATED in 1 BOTTLE (55111-252-01)Marketed from Sep 5, 2007 | |
| 55111-252-05 | 55111025205 | 500 TABLET, FILM COATED in 1 BOTTLE (55111-252-05)Marketed from Sep 5, 2007 | |
| 55111-252-10 | 55111025210 | 1000 TABLET, FILM COATED in 1 BOTTLE (55111-252-10)Marketed from Sep 5, 2007 | |
| 55111-252-30 | 55111025230 | 30 TABLET, FILM COATED in 1 BOTTLE (55111-252-30)Marketed from Sep 5, 2007 | |
| 55111-252-78 | 55111025278 | 10 BLISTER PACK in 1 CARTON (55111-252-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-252-79)Marketed from Sep 5, 2007 |
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)
- Carvedilol
- Generic name (nonproprietary)
- carvedilol
- Active ingredients
- Carvedilol — 3.125 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076649
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 55111-252_31305b0b-ee75-85e9-081c-73d15c0a7b83SPL ID 31305b0b-ee75-85e9-081c-73d15c0a7b83SPL set ID 1e453c21-a8a8-dc54-5591-74c972d41727RxCUI 200031, 200032, 200033, 686924UNII 0K47UL67F2
- Pharmacologic class
- alpha-Adrenergic Blocker; beta-Adrenergic Blocker
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
N455111025201followed by a unit qualifier and the quantityPackage 55111-0252-01. 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 .
Indications (excerpt from the label)
Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: Left ventricular dysfunction following myocardial infarction in clinically stable patients ( 1.2 ) Hypertension ( 1.3 ) 1.2 Left Ventricular Dysfunction Following Myocardial Infarction Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤ 40% (with or without symptomatic heart failure) [see Clinical Studies (14.2) ]. 1.3 Hypertension Carvedilol tablets are indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4) ]. It can…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076649
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-254 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-253 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-255 |