Prescription drug · ANDA
Captopril NDC 0143-1173
Captopril 50 mg/1 · Tablet · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-1173-01 | 00143117301 | 100 TABLET in 1 BOTTLE (0143-1173-01)Marketed from Feb 13, 1996 | |
| 0143-1173-10 | 00143117310 | 1000 TABLET in 1 BOTTLE (0143-1173-10)Marketed from Feb 13, 1996 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Captopril
- Generic name (nonproprietary)
- captopril
- Active ingredients
- Captopril — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074505
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 0143-1173_dcd9332a-1256-457f-900a-b658c6d619c9SPL ID dcd9332a-1256-457f-900a-b658c6d619c9SPL set ID 607687f4-63cf-411c-a20b-21d238a6b7a7RxCUI 308962, 308963, 308964, 317173UNII 9G64RSX1XDUPC 0301431174019, 0301431171018, 0301431173012, 0301431172015
- Pharmacologic class
- Angiotensin Converting Enzyme Inhibitor
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
N400143117301followed by a unit qualifier and the quantityPackage 00143-1173-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Hypertension Captopril Tablets, USP are indicated for the treatment of hypertension. In using Captopril Tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS ). Captopril Tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril Tablets are effective alone and in combination with other antihypert…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074505
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 |
|---|---|---|---|---|
| Captopril | Captopril 25 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-601 |
| Captopril | Captopril 12.5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-600 |
| Captopril | Captopril 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-602 |
| Captopril | Captopril 100 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-603 |
| Captopril | Captopril 12.5 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0143-1171 |
| Captopril | Captopril 25 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0143-1172 |
| Captopril | Captopril 100 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0143-1174 |
| Captopril | Captopril 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 55289-344 |
| Captopril | Captopril 12.5 mg/1 | TabletOral | American Health Packaging | 60687-304 |
| Captopril | Captopril 25 mg/1 | TabletOral | American Health Packaging | 60687-315 |