Potassium Chloride
- Product NDC
- 0378-4561
- 11-digit product format
- 003784561
- Labeler code
- 0378
- Product ID
- 0378-4561_a05e4397-8442-41d9-afa7-832163c3b554
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- potassium chloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA204662
- Marketing category
- ANDA
- Marketing start
- 2016-11-09
- Marketing end
- 2027-01-31
- Substance
- POTASSIUM CHLORIDE
- Active strength
- 10 meq/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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Potassium Chloride
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POTASSIUM CHLORIDE | 10 meq/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 660YQ98I10 |
| Rxcui | 312529, 628953 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-4561-05 | Potassium Chloride | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 500 | | 11 |
| 0378-4561-77 | Potassium Chloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 90 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| POTASSIUM CHLORIDE | ACTIVE INGREDIENT | 660YQ98I10 | POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| POTASSIUM CATION | ACTIVE MOIETY | 295O53K152 | POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-4561 | POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20250501_c64ed4c0-1e27-42b3-9625-fb4e0d31e271.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 |
|---|
| 0378-4561-05 | 00378456105 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4561-05) | 2016-11-09 | 2027-01-31 | No | No | Current |
| 0378-4561-77 | 00378456177 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4561-77) | 2016-11-09 | 2026-11-30 | No | No | Current |