Prescription drug · ANDA
Enalapril maleate and hydrochlorothiazide NDC 55111-134
Enalapril maleate 10 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-134-01 | 5511101340155111013401 | 100 TABLET in 1 BOTTLE (55111-134-01)Marketed from Oct 15, 2001 | |
| 55111-134-10 | 5511101341055111013410 | 1000 TABLET in 1 BOTTLE (55111-134-10)Marketed from Oct 15, 2001 |
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)
- Enalapril maleate and hydrochlorothiazide
- Generic name (nonproprietary)
- enalapril maleate and hydrochlorothiazide
- Active ingredients
- Enalapril maleate — 10 mg/1Hydrochlorothiazide — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories LimitedNDC labeler code 55111
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075909
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 55111-134_8b3e7cd9-3a3d-7b47-d751-09ab6cee3d1bSPL ID 8b3e7cd9-3a3d-7b47-d751-09ab6cee3d1bSPL set ID ed4a55a6-cd6a-c74a-cb93-4b45641691a0RxCUI 858824, 858828UNII 9O25354EPJ, 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
N455111013401followed by a unit qualifier and the quantityPackage 55111-0134-01. 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 Enalapril maleate and hydrochlorothiazide tablets are indicated for the treatment of hypertension. These fixed dose combinations are not indicated for initial treatment (see DOSAGE AND ADMINISTRATION ). In using enalapril maleate 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, and that available data are insufficient to show that enalapril does not have a similar risk (see WARNINGS ). In considering use of Enalapril maleate and hydrochlorothiazide tablets, it should be noted t…
Excerpt only. Read the full label for complete information.
About NDC 55111-134
- What is NDC 55111-134?
- 55111-134 is the product NDC for Enalapril maleate and hydrochlorothiazide, Enalapril maleate 10 mg/1; Hydrochlorothiazide 25 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Enalapril maleate and hydrochlorothiazide.
- What is the active ingredient?
- Enalapril maleate, Hydrochlorothiazide.
- Who is the labeler?
- Dr. Reddy's Laboratories Limited, NDC labeler code 55111. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Enalapril maleate and hydrochlorothiazide?
- 3 other product NDCs are listed under this name. See all Enalapril maleate 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 Enalapril maleate 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) |
|---|---|---|---|---|---|
| Enalapril maleate and hydrochlorothiazide | Enalapril maleate 5 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-133 | 55111-0133-0155111-0133-10 |
| Enalapril Maleate and Hydrochlorothiazide | Enalapril maleate 5 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4045 | 51672-4045-0151672-4045-03 |
| Enalapril Maleate and Hydrochlorothiazide | Enalapril maleate 10 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4046 | 51672-4046-0151672-4046-03 |
Other NDCs under ANDA 075909
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 |
|---|---|---|---|---|
| Enalapril maleate and hydrochlorothiazide | Enalapril maleate 5 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-133 |