Procainamide Hydrochloride
- Product NDC
- 14789-901
- 11-digit product format
- 147890901
- Labeler code
- 14789
- Product ID
- 14789-901_44fbdf17-cfd1-0076-e063-6394a90abf0d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Procainamide Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Nexus Pharmaceuticals LLC
- Application
- ANDA206332
- Marketing category
- ANDA
- Marketing start
- 2007-10-14
- 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 |
|---|
| 14789-901-10 | Procainamide Hydrochloride | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION | 10 | | 16 |
| 14789-901-10 | Procainamide Hydrochloride | 10 in 1 CARTON | INJECTION | 10 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 14789-901 | PROCAINAMIDE HYDROCHLORIDE INJECTION [NEXUS PHARMACEUTICALS LLC] | 14 | Current NDC, Legacy NDC, 2 package rows | 20241127_d58751df-cd8b-45a6-8a32-af19e747e23a.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 |
|---|
| 14789-901-10 | 14789090110 | 10 VIAL, MULTI-DOSE in 1 CARTON (14789-901-10) / 10 mL in 1 VIAL, MULTI-DOSE | 2007-10-14 | 0000-00-00 | No | No | Current |