Prescription drug · ANDA
Bethanechol Chloride NDC 65162-572
Bethanechol chloride 10 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-572-10 | 65162057210 | 100 TABLET in 1 BOTTLE (65162-572-10)Marketed from Nov 21, 2007 | |
| 65162-572-11 | 65162057211 | 1000 TABLET in 1 BOTTLE (65162-572-11)Marketed from Nov 21, 2007 | |
| 65162-572-50 | 65162057250 | 500 TABLET in 1 BOTTLE (65162-572-50)Marketed from Nov 21, 2007 |
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)
- Bethanechol Chloride
- Generic name (nonproprietary)
- bethanechol chloride
- Active ingredients
- Bethanechol chloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040855
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Agonists (Mechanism)
- Identifiers
- Product ID 65162-572_20630162-d16b-4671-a94a-618acea32787SPL ID 20630162-d16b-4671-a94a-618acea32787SPL set ID 45285692-de51-413e-8a51-7fb792eccc81RxCUI 857321, 857328, 857336, 857340UNII H4QBZ2LO84UPC 0365162573107, 0365162574104, 0365162572100, 0365162571103
- Pharmacologic class
- Cholinergic Muscarinic Agonist
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
N465162057210followed by a unit qualifier and the quantityPackage 65162-0572-10. 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)
INDICATIONS AND USAGE Bethanechol chloride tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
Excerpt only. Read the full label for complete information.
About NDC 65162-572
- What is NDC 65162-572?
- 65162-572 is the product NDC for Bethanechol Chloride, Bethanechol chloride 10 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bethanechol Chloride.
- What is the active ingredient?
- Bethanechol chloride.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bethanechol Chloride?
- 21 other product NDCs are listed under this name. See all Bethanechol Chloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bethanechol Chloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bethanechol Chloride | Bethanechol chloride 50 mg/1 | TabletOral | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | 23155-937 | 23155-0937-01 |
| Bethanechol Chloride | Bethanechol chloride 5 mg/1 | TabletOral | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | 23155-934 | 23155-0934-01 |
| Bethanechol Chloride | Bethanechol chloride 10 mg/1 | TabletOral | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | 23155-935 | 23155-0935-01 |
| Bethanechol Chloride | Bethanechol chloride 25 mg/1 | TabletOral | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | 23155-936 | 23155-0936-01 |
| Bethanechol Chloride | Bethanechol chloride 25 mg/1 | TabletOral | American Health Packaging | 60687-700 | 60687-0700-01 |
| Bethanechol Chloride | Bethanechol chloride 10 mg/1 | TabletOral | American Health Packaging | 60687-689 | 60687-0689-01 |
| Bethanechol Chloride | Bethanechol chloride 10 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-572 | 53746-0572-01 |
| Bethanechol Chloride | Bethanechol chloride 5 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-571 | 53746-0571-01 |
| Bethanechol Chloride | Bethanechol chloride 25 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-573 | 53746-0573-01 |
| Bethanechol Chloride | Bethanechol chloride 50 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-574 | 53746-0574-01 |
Other NDCs under ANDA 040855
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 |
|---|---|---|---|---|
| Bethanechol Chloride | Bethanechol chloride 10 mg/1 | TabletOral | American Health Packaging | 60687-689 |
| Bethanechol Chloride | Bethanechol chloride 25 mg/1 | TabletOral | American Health Packaging | 60687-700 |
| Bethanechol Chloride | Bethanechol chloride 10 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-572 |
| Bethanechol Chloride | Bethanechol chloride 5 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-571 |
| Bethanechol Chloride | Bethanechol chloride 25 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-573 |
| Bethanechol Chloride | Bethanechol chloride 50 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-574 |
| Bethanechol Chloride | Bethanechol chloride 5 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-571 |
| Bethanechol Chloride | Bethanechol chloride 25 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-573 |
| Bethanechol Chloride | Bethanechol chloride 50 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-574 |