Prescription drug · ANDA
Fosinopril Sodium and Hydrochlorothiazide NDC 65862-308
Fosinopril sodium 10 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-308-01 | 6586203080165862030801 | 100 TABLET in 1 BOTTLE (65862-308-01)Marketed from Jul 9, 2009 | |
| 65862-308-30 | 6586203083065862030830 | 30 TABLET in 1 BOTTLE (65862-308-30)Marketed from Jul 9, 2009 | |
| 65862-308-99 | 6586203089965862030899 | 1000 TABLET in 1 BOTTLE (65862-308-99)Marketed from Jul 9, 2009 |
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)
- Fosinopril Sodium and Hydrochlorothiazide
- Generic name (nonproprietary)
- fosinopril sodium and hydrochlorothiazide
- Active ingredients
- Fosinopril sodium — 10 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079245
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 65862-308_34bf0456-37d0-4d7d-a585-1555b7bc9373SPL ID 34bf0456-37d0-4d7d-a585-1555b7bc9373SPL set ID 35019655-9a30-4305-a262-936ad0e73071RxCUI 857166, 857174UNII NW2RTH6T2N, 0J48LPH2TH
- Pharmacologic class
- Angiotensin Converting Enzyme Inhibitor; 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
N465862030801followed by a unit qualifier and the quantityPackage 65862-0308-01. 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 Fosinopril sodium and hydrochlorothiazide tablets are indicated for the treatment of hypertension. These fixed dose combinations are not indicated for initial therapy. (See DOSAGE AND ADMINISTRATION . ) In using fosinopril sodium and hydrochlorothiazide, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis ). ACE inhibitors (for which adequate data are available) cause a higher rate of an…
Excerpt only. Read the full label for complete information.
About NDC 65862-308
- What is NDC 65862-308?
- 65862-308 is the product NDC for Fosinopril Sodium and Hydrochlorothiazide, Fosinopril sodium 10 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fosinopril Sodium and Hydrochlorothiazide.
- What is the active ingredient?
- Fosinopril sodium, Hydrochlorothiazide.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fosinopril Sodium and Hydrochlorothiazide?
- 3 other product NDCs are listed under this name. See all Fosinopril Sodium and Hydrochlorothiazide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fosinopril Sodium and Hydrochlorothiazide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fosinopril Sodium and Hydrochlorothiazide | Fosinopril sodium 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | CIPLA USA INC. | 69097-972 | 69097-0972-07 |
| Fosinopril Sodium and Hydrochlorothiazide | Fosinopril sodium 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | CIPLA USA INC. | 69097-973 | 69097-0973-07 |
| Fosinopril Sodium and Hydrochlorothiazide | Fosinopril sodium 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-309 | 65862-0309-0165862-0309-3065862-0309-99 |
Other NDCs under ANDA 079245
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 |
|---|---|---|---|---|
| Fosinopril Sodium and Hydrochlorothiazide | Fosinopril sodium 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-309 |