Prescription drug · NDA AUTHORIZED GENERIC
Spironolactone and Hydrochlorothiazide NDC 66993-188
Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet, Film coated · Oral · Prasco Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66993-188-02 | 6699301880266993018802 | 100 TABLET, FILM COATED in 1 BOTTLE (66993-188-02)Marketed from Nov 29, 2021 |
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)
- Spironolactone and Hydrochlorothiazide
- Generic name (nonproprietary)
- spironolactone and hydrochlorothiazide
- Active ingredients
- Spironolactone — 25 mg/1Hydrochlorothiazide — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Prasco LaboratoriesNDC labeler code 66993
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 012616
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 66993-188_eca75090-9808-4673-bd7e-1ecd571d3b3eSPL ID eca75090-9808-4673-bd7e-1ecd571d3b3eSPL set ID 9d350fa2-d568-4970-a7a5-d128ff5d0a2fRxCUI 198224UNII 27O7W4T232, 0J48LPH2THUPC 0366993188027
- Pharmacologic class
- Aldosterone Antagonist; 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
N466993018802followed by a unit qualifier and the quantityPackage 66993-0188-02. 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)
INDICATIONS AND USAGE Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions section). Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described below. Unnecessary use of this drug should be avoided. Spironolactone and hydrochlorothiazide tablets are indicated for: Edematous conditions for patients with: Congestive heart failure: • For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures; • The treatment of diuretic-induced hypokalemia in patients with co…
Excerpt only. Read the full label for complete information.
About NDC 66993-188
- What is NDC 66993-188?
- 66993-188 is the product NDC for Spironolactone and Hydrochlorothiazide, Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 tablet, film coated, listed with the FDA by Prasco Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Spironolactone and Hydrochlorothiazide.
- What is the active ingredient?
- Spironolactone, Hydrochlorothiazide.
- Who is the labeler?
- Prasco Laboratories, NDC labeler code 66993. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Spironolactone and Hydrochlorothiazide?
- 11 other product NDCs are listed under this name. See all Spironolactone 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 Spironolactone 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) |
|---|---|---|---|---|---|
| Spironolactone and hydrochlorothiazide | Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Advagen Pharma Ltd. | 72888-040 | 72888-0040-0172888-0040-0272888-0040-03 |
| Spironolactone and Hydrochlorothiazide | Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Safecor Health LLC | 48433-090 | 48433-0090-20 |
| Spironolactone and Hydrochlorothiazide | Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Mylan Institutional Inc. | 42292-017 | 42292-0017-20 |
| Spironolactone and Hydrochlorothiazide | Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 53489-144 | 53489-0144-0153489-0144-0553489-0144-10 |
| Spironolactone and Hydrochlorothiazide | Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1068 | 63629-1068-01 |
| Spironolactone and Hydrochlorothiazide | Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1069 | 63629-1069-01 |
| Spironolactone and Hydrochlorothiazide | Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1071 | 63629-1071-0163629-1071-0263629-1071-03 |
| Spironolactone and Hydrochlorothiazide | Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2202 | 71335-2202-01 |
| Spironolactone and Hydrochlorothiazide | Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2674 | 71335-2674-0171335-2674-0271335-2674-03 |
| Spironolactone and Hydrochlorothiazide | Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1625 | 72162-1625-0072162-1625-0172162-1625-03+3 more |