Quinidine Gluconate
- Product NDC
- 54738-901
- 11-digit product format
- 547380901
- Labeler code
- 54738
- Product ID
- 54738-901_09624157-b39f-4a90-9651-17eeac2ce39c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quinidine Gluconate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Richmond Pharmaceuticals, Inc.
- Application
- ANDA089338
- Marketing category
- ANDA
- Marketing start
- 1987-02-10
- Marketing end
- 0000-00-00
- Substance
- QUINIDINE GLUCONATE
- Active strength
- 324 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Quinidine Gluconate | ACTIVE INGREDIENT | R6875N380F | QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [RICHMOND PHARMACEUTICALS, INC.] | 2 | |
| Quinidine | ACTIVE MOIETY | ITX08688JL | QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [RICHMOND PHARMACEUTICALS, INC.] | 2 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [RICHMOND PHARMACEUTICALS, INC.] | 2 | |
| hypromellose 2208 (15000 mpa.s) | INACTIVE INGREDIENT | Z78RG6M2N2 | QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [RICHMOND PHARMACEUTICALS, INC.] | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [RICHMOND PHARMACEUTICALS, INC.] | 2 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [RICHMOND PHARMACEUTICALS, INC.] | 2 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [RICHMOND PHARMACEUTICALS, INC.] | 2 | |
| sodium alginate | INACTIVE INGREDIENT | C269C4G2ZQ | QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [RICHMOND PHARMACEUTICALS, INC.] | 2 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [RICHMOND PHARMACEUTICALS, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54738-901 | QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [RICHMOND PHARMACEUTICALS, INC.] | 5 | Legacy NDC | 20190305_4fb02ad7-6e93-4aff-9aca-5162559b99a5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54738-901-01 | 54738090101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54738-901-01) | 1987-02-10 | 0000-00-00 | No | No | Current |
| 54738-901-02 | 54738090102 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54738-901-02) | 1987-02-10 | 0000-00-00 | No | No | Current |