Potassium Chloride
- Product NDC
- 53746-542
- 11-digit product format
- 537460542
- Labeler code
- 53746
- Product ID
- 53746-542_39798c58-3f69-43f2-b103-9da28abbeeba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Potassium Chloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA202128
- Marketing category
- ANDA
- Marketing start
- 2013-02-22
- Substance
- POTASSIUM CHLORIDE
- Active strength
- 750 mg/1
- Pharmacologic classes
- Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Potassium Chloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POTASSIUM CHLORIDE | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 660YQ98I10 |
| Rxcui | 312504 |
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 |
|---|
| 53746-542-01 | Potassium Chloride | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | | 17 |
| 53746-542-05 | Potassium Chloride | 500 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 500 | | 17 |
| 53746-542-10 | Potassium Chloride | 1000 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 1000 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| POTASSIUM CHLORIDE | ACTIVE INGREDIENT | 660YQ98I10 | POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| POTASSIUM CATION | ACTIVE MOIETY | 295O53K152 | POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-542 | POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 17 | Current NDC, Legacy NDC, 3 package rows | 20240413_cd56e147-92d6-46ce-ae00-63fac08d49b5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53746-542-01 | 53746054201 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53746-542-01) | 2013-02-22 | 0000-00-00 | No | No | Current |
| 53746-542-05 | 53746054205 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53746-542-05) | 2013-02-22 | 0000-00-00 | No | No | Current |
| 53746-542-10 | 53746054210 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53746-542-10) | 2013-02-22 | 0000-00-00 | No | No | Current |