Prescription drug · ANDA
Potassium Chloride Extended Release (Potassium chloride) NDC 70010-022
Potassium chloride 750 mg/1 · Tablet, Extended release · Oral · Granules Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70010-022-01 | 7001000220170010002201 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-022-01)Marketed from Oct 22, 2020 | |
| 70010-022-05 | 7001000220570010002205 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-022-05)Marketed from Oct 22, 2020 | |
| 70010-022-10 | 7001000221070010002210 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-022-10)Marketed from May 4, 2021 | |
| 70010-022-61 | 7001000226170010002261 | 3 BLISTER PACK in 1 CARTON (70010-022-61) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jan 3, 2022 | |
| 70010-022-62 | 7001000226270010002262 | 10 BLISTER PACK in 1 CARTON (70010-022-62) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jan 3, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Potassium Chloride Extended Release
- Generic name (nonproprietary)
- potassium chloride
- Active ingredients
- Potassium chloride — 750 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Granules Pharmaceuticals Inc.NDC labeler code 70010
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211797
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)
- Identifiers
- Product ID 70010-022_f33d5a34-e5e7-a85f-e053-2995a90a6db3SPL ID f33d5a34-e5e7-a85f-e053-2995a90a6db3SPL set ID 9f8d2886-9ecd-4cbf-a84a-2d221cb3497cRxCUI 312529, 628953UNII 660YQ98I10
- Pharmacologic class
- Osmotic Laxative; Potassium Salt
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470010002201followed by a unit qualifier and the quantityPackage 70010-0022-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. Potassium chloride extended-release tablets are a potassium salt, indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.( 1 )
Excerpt only. Read the full label for complete information.
About NDC 70010-022
- What is NDC 70010-022?
- 70010-022 is the product NDC for Potassium Chloride Extended Release, Potassium chloride 750 mg/1 tablet, extended release, listed with the FDA by Granules Pharmaceuticals Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Potassium Chloride Extended Release (Potassium chloride).
- What is the active ingredient?
- Potassium chloride.
- Who is the labeler?
- Granules Pharmaceuticals Inc., NDC labeler code 70010. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Potassium Chloride Extended Release?
- 45 other product NDCs are listed under this name. See all Potassium Chloride Extended Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Potassium Chloride Extended Release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Potassium Chloride Extended-Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Major Pharmaceuticals | 0904-7547 | 00904-7547-61 |
| Potassium Chloride Extended Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4520 | 70518-4520-00 |
| Potassium Chloride Extended-release | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4383 | 70518-4383-0070518-4383-0170518-4383-02 |
| Potassium Chloride Extended Releasepotassium chloride | Potassium chloride 600 mg/1 | Tablet, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-842 | 16571-0842-0116571-0842-1016571-0842-50 |
| Potassium Chloride Extended Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-843 | 16571-0843-0116571-0843-1016571-0843-50 |
| Potassium Chloride Extended-release | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4095 | 70518-4095-0270518-4095-03 |
| Potassium Chloride Extended-Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-231 | 24979-0231-0124979-0231-0224979-0231-03 |
| Potassium Chloride Extended-Releasepotassium chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-232 | 24979-0232-0124979-0232-02 |
| Potassium Chloride Extended-Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6639 | 50090-6639-0050090-6639-0150090-6639-02+1 more |
| Potassium Chloride Extended-Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6640 | 50090-6640-00 |
Other NDCs under ANDA 211797
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Potassium Chloride Extended Releasepotassium chloride | Potassium chloride 600 mg/1 | Tablet, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-021 |
| Potassium Chloride Extended Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4520 |
| Potassium Chloride Extended Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-932 |