Bethanechol Chloride
- Product NDC
- 65162-574
- 11-digit product format
- 651620574
- Labeler code
- 65162
- Product ID
- 65162-574_20630162-d16b-4671-a94a-618acea32787
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bethanechol Chloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA040855
- Marketing category
- ANDA
- Marketing start
- 2007-11-21
- Substance
- BETHANECHOL CHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bethanechol Chloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BETHANECHOL CHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H4QBZ2LO84 |
| Rxcui | 857321, 857328, 857336, 857340 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-574-10 | Bethanechol Chloride | 100 in 1 BOTTLE | TABLET | 100 | | 15 |
| 65162-574-50 | Bethanechol Chloride | 500 in 1 BOTTLE | TABLET | 500 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BETHANECHOL CHLORIDE | ACTIVE INGREDIENT | H4QBZ2LO84 | BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| BETHANECHOL | ACTIVE MOIETY | 004F72P8F4 | BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| BETHANECHOL CHLORIDE | ACTIVE INGREDIENT | H4QBZ2LO84 | BETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| BETHANECHOL | ACTIVE MOIETY | 004F72P8F4 | BETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | BETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | BETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | BETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | BETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-574 | BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS LLC] | 15 | Current NDC, Legacy NDC, 2 package rows | 20241025_45285692-de51-413e-8a51-7fb792eccc81.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-574-10 | 65162057410 | 100 TABLET in 1 BOTTLE (65162-574-10) | 100 tablet | 2007-11-21 | 0000-00-00 | No | No | Current |
| 65162-574-50 | 65162057450 | 500 TABLET in 1 BOTTLE (65162-574-50) | 500 tablet | 2007-11-21 | 0000-00-00 | No | No | Current |