Prescription drug · ANDA
Fosinopril Sodium and Hydrochlorothiazide NDC 69097-973
Fosinopril sodium 20 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · CIPLA USA INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-973-07 | 6909709730769097097307 | 100 TABLET in 1 BOTTLE (69097-973-07)Marketed from Jul 24, 2020 |
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 — 20 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- CIPLA USA INC.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090228
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 69097-973_25e66ad5-947a-4262-a996-a9695601d301SPL ID 25e66ad5-947a-4262-a996-a9695601d301SPL set ID 4e1ed7da-029e-48d6-a5e4-fc7ac11192fbRxCUI 857166, 857174UNII NW2RTH6T2N, 0J48LPH2THUPC 0369097973070, 0369097972073
- 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
N469097097307followed by a unit qualifier and the quantityPackage 69097-0973-07. 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 tablets, 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…
Excerpt only. Read the full label for complete information.
About NDC 69097-973
- What is NDC 69097-973?
- 69097-973 is the product NDC for Fosinopril Sodium and Hydrochlorothiazide, Fosinopril sodium 20 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, listed with the FDA by CIPLA USA INC.. It has 1 package NDC, 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?
- CIPLA USA INC., NDC labeler code 69097. 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 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-308 | 65862-0308-0165862-0308-3065862-0308-99 |
| 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 090228
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 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | CIPLA USA INC. | 69097-972 |