amiloride hydrochloride
- Product NDC
- 57721-671
- 11-digit product format
- 577210671
- Labeler code
- 57721
- Product ID
- 57721-671_c7011dc8-3456-83c7-e053-2995a90ac7d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amiloride hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- WINDLAS BIOTECH LIMITED
- Application
- ANDA204180
- Marketing category
- ANDA
- Marketing start
- 2021-12-01
- Marketing end
- 0000-00-00
- Substance
- AMILORIDE HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57721-671-01 | amiloride hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 57721-671-05 | amiloride hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 5 |
| 57721-671-06 | amiloride hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 57721-671-10 | amiloride hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 5 |
| 57721-671-16 | amiloride hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
| 57721-671-30 | amiloride hydrochloride | 10 in 1 BLISTER PACK | TABLET | 10 | | 5 |
| 57721-671-30 | amiloride hydrochloride | 10 in 1 CARTON | TABLET | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57721-671 | AMILORIDE HYDROCHLORIDE TABLET [WINDLAS BIOTECH LIMITED] | 5 | Legacy NDC, 7 package rows | 20211201_60e8e566-28c6-99ba-e053-2a91aa0a8dbe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57721-671-01 | 57721067101 | 100 TABLET in 1 BOTTLE (57721-671-01) | 100 tablet | 2021-12-01 | 0000-00-00 | No | No | Current |
| 57721-671-05 | 57721067105 | 500 TABLET in 1 BOTTLE (57721-671-05) | 500 tablet | 2021-12-01 | 0000-00-00 | No | No | Current |
| 57721-671-06 | 57721067106 | 30 TABLET in 1 BOTTLE (57721-671-06) | 30 tablet | 2021-12-01 | 0000-00-00 | No | No | Current |
| 57721-671-10 | 57721067110 | 1000 TABLET in 1 BOTTLE (57721-671-10) | 1000 tablet | 2021-12-01 | 0000-00-00 | No | No | Current |
| 57721-671-16 | 57721067116 | 90 TABLET in 1 BOTTLE (57721-671-16) | 90 tablet | 2021-12-01 | 0000-00-00 | No | No | Current |
| 57721-671-30 | 57721067130 | 10 BLISTER PACK in 1 CARTON (57721-671-30) > 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2021-12-01 | 0000-00-00 | No | No | Current |