propafenone hydrochloride
- Product NDC
- 68462-408
- 11-digit product format
- 684620408
- Labeler code
- 68462
- Product ID
- 68462-408_9b3e09a2-c396-425e-a1dc-e37cd44b612d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- propafenone hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA205268
- Marketing category
- ANDA
- Marketing start
- 2017-09-08
- Substance
- PROPAFENONE HYDROCHLORIDE
- Active strength
- 225 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- propafenone hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROPAFENONE HYDROCHLORIDE | 225 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33XCH0HOCD |
| Rxcui | 861156, 861164, 861171 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-408-60 | propafenone hydrochloride | 60 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 60 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-408 | PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240104_d818af31-2535-4595-82fe-fd7abf66fd6c.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 |
|---|
| 68462-408-60 | 68462040860 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-408-60) | 2017-09-08 | 0000-00-00 | No | No | Current |