Procainamide Hydrochloride
- Product NDC
- 84549-399
- 11-digit product format
- 845490399
- Labeler code
- 84549
- Product ID
- 84549-399_3d5d9d6e-1f1d-7565-e063-6394a90a93e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Procainamide Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- ProPharma Distribution
- Application
- ANDA088636
- Marketing category
- ANDA
- Marketing start
- 2016-12-21
- 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 | 1862220 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84549-399-05 | Procainamide Hydrochloride | 10 mL in 1 SYRINGE | INJECTION | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84549-399-05 | 84549039905 | 10 mL in 1 SYRINGE (84549-399-05) | 10 ml | 2025-09-01 | No | No | Historical |