Propafenone HCl
- Product NDC
- 0591-0583
- 11-digit product format
- 005910583
- Labeler code
- 0591
- Product ID
- 0591-0583_71d5cee6-245f-4d4a-8a59-e555c3ca4573
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Propafenone hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA075203
- Marketing category
- ANDA
- Marketing start
- 2000-10-24
- Marketing end
- 0000-00-00
- Substance
- PROPAFENONE HYDROCHLORIDE
- Active strength
- 225 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-0583-01 | Propafenone HCl | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PROPAFENONE HYDROCHLORIDE | ACTIVE INGREDIENT | 33XCH0HOCD | PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 17 | |
| PROPAFENONE | ACTIVE MOIETY | 68IQX3T69U | PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 17 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 17 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 17 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 17 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 17 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 17 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 17 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 17 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 17 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 17 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 17 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 17 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 17 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-0583 | PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 23 | Legacy NDC, 1 package rows | 20190326_a313c111-e539-47bc-9d57-c3767f74bcca.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 |
|---|
| 0591-0583-01 | 00591058301 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0583-01) | 2000-10-24 | 0000-00-00 | No | No | Current |