PROCAINAMIDE HYDROCHLORIDE
- Product NDC
- 51662-1630
- 11-digit product format
- 516621630
- Labeler code
- 51662
- Product ID
- 51662-1630_39ae5dd3-dcaa-d40f-e063-6294a90a78af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROCAINAMIDE HYDROCHLORIDE
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA088636
- Marketing category
- ANDA
- Marketing start
- 2023-06-23
- 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 |
|---|
| 51662-1630-1 | PROCAINAMIDE HYDROCHLORIDE | 10 mL in 1 SYRINGE | INJECTION | 10 | | 4 |
| 51662-1630-2 | PROCAINAMIDE HYDROCHLORIDE | 1 in 1 BOX | INJECTION | 1 | | 4 |
| 51662-1630-2 | PROCAINAMIDE HYDROCHLORIDE | 1 in 1 POUCH | INJECTION | 1 | | 4 |
| 51662-1630-3 | PROCAINAMIDE HYDROCHLORIDE | 5 in 1 CASE | INJECTION | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1630 | PROCAINAMIDE HYDROCHLORIDE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 3 | Current NDC, 4 package rows | 20240123_fece65c0-fdbc-61d8-e053-6294a90a9a68.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 |
|---|
| 51662-1630-1 | 51662163001 | 10 mL in 1 SYRINGE | 10 ml | | | | Historical |
| 51662-1630-2 | 51662163002 | 1 in 1 BOX | | | | | Historical |
| 51662-1630-3 | 51662163003 | 5 POUCH in 1 CASE (51662-1630-3) / 1 BOX in 1 POUCH (51662-1630-2) / 1 SYRINGE in 1 BOX / 10 mL in 1 SYRINGE (51662-1630-1) | 5 pouch | 2023-06-23 | No | No | Historical |