Procainamide Hydrochloride
- Product NDC
- 68083-603
- 11-digit product format
- 680830603
- Labeler code
- 68083
- Product ID
- 68083-603_e8e25e4b-14ce-40cb-85d9-4cc78ca9e807
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Procainamide Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA218135
- Marketing category
- ANDA
- Marketing start
- 2024-07-22
- 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 |
|---|
| 68083-603-01 | Procainamide Hydrochloride | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 3 |
| 68083-603-01 | Procainamide Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
| 68083-603-25 | Procainamide Hydrochloride | 25 in 1 CASE | INJECTION, SOLUTION | 25 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-603 | PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 3 | Current NDC, 3 package rows | 20240730_ffde440f-7ad7-434c-bcd2-9bd8ff16d204.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 |
|---|
| 68083-603-01 | 68083060301 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | Historical |
| 68083-603-25 | 68083060325 | 25 CARTON in 1 CASE (68083-603-25) / 1 VIAL, MULTI-DOSE in 1 CARTON (68083-603-01) / 10 mL in 1 VIAL, MULTI-DOSE | 25 carton | 2024-07-22 | No | No | Current |