Procainamide Hydrochloride
- Product NDC
- 76329-3399
- 11-digit product format
- 763293399
- Labeler code
- 76329
- Product ID
- 76329-3399_f3adde99-01db-4dee-a59d-9434cbb88495
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Procainamide Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- International Medication Systems, Limited
- 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 |
|---|
| 76329-3399-5 | Procainamide Hydrochloride | 5 in 1 PACKAGE | INJECTION | 5 | | 1 |
| 76329-3399-5 | Procainamide Hydrochloride | 10 mL in 1 SYRINGE | INJECTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76329-3399 | PROCAINAMIDE HYDROCHLORIDE INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED] | 1 | Current NDC, Legacy NDC, 2 package rows | 20161221_d7cb1594-61cf-41c4-9007-1ee28aa69c50.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76329-3399-5 | 76329339905 | 5 SYRINGE in 1 PACKAGE (76329-3399-5) / 10 mL in 1 SYRINGE | 5 syringe | 2016-12-21 | 0000-00-00 | No | No | Current |