PROPAFENONE HYDROCHLORIDE
- Product NDC
- 59651-257
- 11-digit product format
- 596510257
- Labeler code
- 59651
- Product ID
- 59651-257_b59b252f-8b73-4f72-8d01-4d2076c18fa6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROPAFENONE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202445
- Marketing category
- ANDA
- Marketing start
- 2019-10-25
- Substance
- PROPAFENONE HYDROCHLORIDE
- Active strength
- 225 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PROPAFENONE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROPAFENONE HYDROCHLORIDE | 225 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33XCH0HOCD |
| Rxcui | 861424, 861427, 861430 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-257-01 | PROPAFENONE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 59651-257-33 | PROPAFENONE HYDROCHLORIDE | 300 in 1 BOTTLE | TABLET, FILM COATED | 300 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-257 | PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20230722_0c887381-42fe-4f37-858a-d9ffb218dd1c.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 |
|---|
| 59651-257-01 | 59651025701 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-257-01) | 2019-10-25 | 0000-00-00 | No | No | Current |
| 59651-257-33 | 59651025733 | 300 TABLET, FILM COATED in 1 BOTTLE (59651-257-33) | 2019-10-25 | 0000-00-00 | No | No | Current |