PROPAFENONE HYDROCHLORIDE
- Product NDC
- 64380-268
- 11-digit product format
- 643800268
- Labeler code
- 64380
- Product ID
- 64380-268_c59340fa-0b07-454a-bf5a-c49b54bfd42c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROPAFENONE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA075938
- Marketing category
- ANDA
- Marketing start
- 2025-05-05
- 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 | 861424, 861427, 861430 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-268-01 | PROPAFENONE HYDROCHLORIDE | 300 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 300 | | 3 |
| 64380-268-02 | PROPAFENONE HYDROCHLORIDE | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-268 | PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED] | 2 | Current NDC, 2 package rows | 20250507_c65253ab-937f-4982-b841-69c2b9f9ccdb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 64380-268-01 | 64380026801 | 300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-268-01) | 2025-05-05 | No | No | Current |
| 64380-268-02 | 64380026802 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-268-02) | 2025-05-05 | No | No | Current |