Amiloride Hydrochloride
- Product NDC
- 42794-005
- 11-digit product format
- 427940005
- Labeler code
- 42794
- Product ID
- 42794-005_f1f15fe7-63a8-4708-e053-2a95a90a7dea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiloride Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sigmapharm Laboratories, LLC
- Application
- ANDA079133
- Marketing category
- ANDA
- Marketing start
- 2021-06-14
- Substance
- AMILORIDE HYDROCHLORIDE ANHYDROUS
- 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 ANHYDROUS | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7M458Q65S3 |
| Rxcui | 977880 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42794-005-02 | Amiloride Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42794-005 | AMILORIDE HYDROCHLORIDE TABLET [SIGMAPHARM LABORATORIES, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230111_de12b6f3-3791-4d78-90e6-c487cf951738.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 |
|---|
| 42794-005-02 | 42794000502 | 100 TABLET in 1 BOTTLE (42794-005-02) | 100 tablet | 2021-06-14 | 0000-00-00 | No | No | Current |