Spironolactone
- Product NDC
- 70518-3655
- 11-digit product format
- 705183655
- Labeler code
- 70518
- Product ID
- 70518-3655_4f708850-9d08-adfe-e063-6294a90add6a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA040750
- Marketing category
- ANDA
- Marketing start
- 2023-02-21
- Substance
- SPIRONOLACTONE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Spironolactone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SPIRONOLACTONE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 27O7W4T232 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3655-0 | Spironolactone | 30 in 1 BLISTER PACK | TABLET, COATED | 30 | | 7 |
| 70518-3655-1 | Spironolactone | 90 in 1 BOTTLE, PLASTIC | TABLET, COATED | 90 | | 7 |
| 70518-3655-2 | Spironolactone | 30 in 1 BLISTER PACK | TABLET, COATED | 30 | | 7 |
| 70518-3655-3 | Spironolactone | 100 in 1 BOX | TABLET, COATED | 100 | | 7 |
| 70518-3655-4 | Spironolactone | 1 in 1 POUCH | TABLET, COATED | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3655 | SPIRONOLACTONE TABLET, COATED [REMEDYREPACK INC.] | 4 | Current NDC, 5 package rows | 20241013_b119ed8a-289a-46c5-9778-6b07e4c061c4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3655-0 | 70518365500 | 30 in 1 BLISTER PACK | | | | | Historical |
| 70518-3655-1 | 70518365501 | 90 in 1 BOTTLE, PLASTIC | | | | | Historical |
| 70518-3655-2 | 70518365502 | 30 TABLET, COATED in 1 BLISTER PACK (70518-3655-2) | | 2023-04-10 | No | No | Historical |
| 70518-3655-3 | 70518365503 | 100 POUCH in 1 BOX (70518-3655-3) / 1 TABLET, COATED in 1 POUCH (70518-3655-4) | 100 pouch | 2025-08-17 | No | No | Historical |
| 70518-3655-4 | 70518365504 | 1 in 1 POUCH | | | | | Historical |