Potassium Chloride
- Product NDC
- 50090-5335
- 11-digit product format
- 500905335
- Labeler code
- 50090
- Product ID
- 50090-5335_dbf5cc65-196b-4d7c-a311-d30c7d9fef63
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Potassium Chloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA210921
- Marketing category
- ANDA
- Marketing start
- 2018-12-19
- 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 | 628953 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-5335-0 | 2023-02-06 | C162847 | 48780-1 | f386c649-c61a-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS. POTASSIUM CHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1948 |
| 50090-5335-1 | 2023-02-06 | C162847 | 48780-1 | f386c649-c61a-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS. POTASSIUM CHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1948 |
| 50090-5335-2 | 2023-02-06 | C162847 | 48780-1 | f386c649-c61a-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS. POTASSIUM CHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1948 |
| 50090-5335-3 | 2023-02-06 | C162847 | 48780-1 | f386c649-c61a-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS. POTASSIUM CHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1948 |
| 50090-5335-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-c61a-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS. POTASSIUM CHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1948 |
| 50090-5335-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-c61a-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS. POTASSIUM CHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1948 |
| 50090-5335-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-c61a-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS. POTASSIUM CHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1948 |
| 50090-5335-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-c61a-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS. POTASSIUM CHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1948 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-5335-0 | Potassium Chloride | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 9 |
| 50090-5335-1 | Potassium Chloride | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 9 |
| 50090-5335-2 | Potassium Chloride | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 9 |
| 50090-5335-3 | Potassium Chloride | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5335 | POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 9 | Current NDC, Legacy NDC, 4 package rows | 20230919_e1670127-c551-441b-bac4-39f10a6d156f.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 |
|---|
| 50090-5335-0 | 50090533500 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5335-0) | 2020-11-04 | 0000-00-00 | No | No | Current |
| 50090-5335-1 | 50090533501 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5335-1) | 2020-11-04 | 0000-00-00 | No | No | Current |
| 50090-5335-2 | 50090533502 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5335-2) | 2020-11-04 | 0000-00-00 | No | No | Current |
| 50090-5335-3 | 50090533503 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5335-3) | 2020-11-04 | 0000-00-00 | No | No | Current |