Ropivacaine Hydrochloride
- Product NDC
- 70121-1734
- 11-digit product format
- 701211734
- Labeler code
- 70121
- Product ID
- 70121-1734_aa7176ac-f262-4470-a4de-60e288c05ac3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ropivacaine Hydrochloride
- Dosage form
- INJECTION
- Route
- EPIDURAL; INFILTRATION; PERINEURAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA216605
- Marketing category
- ANDA
- Marketing start
- 2023-03-17
- Substance
- ROPIVACAINE HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ropivacaine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROPIVACAINE HYDROCHLORIDE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V910P86109 |
| Rxcui | 1734347, 1734355, 1734479, 1734481 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70121-1734-3 | Ropivacaine Hydrochloride | 12 in 1 CARTON | INJECTION | 12 | | 12 |
| 70121-1734-3 | Ropivacaine Hydrochloride | 1 in 1 POUCH | INJECTION | 1 | | 12 |
| 70121-1734-7 | Ropivacaine Hydrochloride | 10 in 1 CARTON | INJECTION | 10 | | 12 |
| 70121-1734-7 | Ropivacaine Hydrochloride | 1 in 1 POUCH | INJECTION | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70121-1734 | ROPIVACAINE HYDROCHLORIDE INJECTION [AMNEAL PHARMACEUTICALS LLC] | 12 | Current NDC, 4 package rows | 20250309_da1ce22b-6a8e-40a2-afbb-011fa3ed3a8b.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 |
|---|
| 70121-1734-3 | 70121173403 | 12 POUCH in 1 CARTON (70121-1734-3) / 1 BAG in 1 POUCH / 100 mL in 1 BAG | 12 pouch | 2023-12-04 | No | No | Historical |
| 70121-1734-7 | 70121173407 | 10 POUCH in 1 CARTON (70121-1734-7) / 1 BAG in 1 POUCH / 100 mL in 1 BAG | 10 pouch | 2023-03-17 | No | No | Historical |