Procainamide Hydrochloride
- Product NDC
- 65145-155
- 11-digit product format
- 651450155
- Labeler code
- 65145
- Product ID
- 65145-155_b7308804-0dc7-4740-8041-1dd391f950a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Procainamide Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Caplin Steriles Limited
- Application
- ANDA218674
- Marketing category
- ANDA
- Marketing start
- 2025-02-17
- Substance
- PROCAINAMIDE HYDROCHLORIDE
- Active strength
- 100 mg/mL
- 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
- Procainamide Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROCAINAMIDE HYDROCHLORIDE | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SI4064O0LX |
| Rxcui | 857886, 857962 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65145-155-01 | Procainamide Hydrochloride | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 2 |
| 65145-155-10 | Procainamide Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65145-155 | PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [CAPLIN STERILES LIMITED] | 2 | Current NDC, 2 package rows | 20250221_fcaa5e9a-3c8a-4796-aa87-626268b6cf60.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65145-155-01 | 65145015501 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | Historical |
| 65145-155-10 | 65145015510 | 10 VIAL, MULTI-DOSE in 1 CARTON (65145-155-10) / 10 mL in 1 VIAL, MULTI-DOSE (65145-155-01) | | 2025-02-17 | No | No | Current |