amiloride hydrochloride
- Product NDC
- 0574-0292
- 11-digit product format
- 005740292
- Labeler code
- 0574
- Product ID
- 0574-0292_416c3aaf-7390-40cf-995a-31258156b4f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amiloride hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Padagis US LLC
- Application
- NDA018200
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2009-04-06
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- amiloride hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMILORIDE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FZJ37245UC |
| Rxcui | 977880 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0574-0292-01 | amiloride hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMILORIDE HYDROCHLORIDE | ACTIVE INGREDIENT | FZJ37245UC | AMILORIDE HYDROCLORIDE TABLET [PADDOCK LABORATORIES, LLC] | 2 | |
| AMILORIDE | ACTIVE MOIETY | 7DZO8EB0Z3 | AMILORIDE HYDROCLORIDE TABLET [PADDOCK LABORATORIES, LLC] | 2 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | AMILORIDE HYDROCLORIDE TABLET [PADDOCK LABORATORIES, LLC] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | AMILORIDE HYDROCLORIDE TABLET [PADDOCK LABORATORIES, LLC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMILORIDE HYDROCLORIDE TABLET [PADDOCK LABORATORIES, LLC] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AMILORIDE HYDROCLORIDE TABLET [PADDOCK LABORATORIES, LLC] | 2 | |
| AMILORIDE HYDROCHLORIDE | ACTIVE INGREDIENT | FZJ37245UC | AMILORIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| AMILORIDE | ACTIVE MOIETY | 7DZO8EB0Z3 | AMILORIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | AMILORIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMILORIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0574-0292 | AMILORIDE HYDROCHLORIDE TABLET [PADAGIS US LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20241123_2b70cf0c-45be-428f-b396-5001ed4e30fc.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 |
|---|
| 0574-0292-01 | 00574029201 | 100 TABLET in 1 BOTTLE (0574-0292-01) | 100 tablet | 2009-04-06 | 0000-00-00 | No | No | Current |