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NDC 00143-9263-10 Ropivacaine Hydrochloride 2 mg/mL Details
Ropivacaine Hydrochloride 2 mg/mL
Ropivacaine Hydrochloride is a EPIDURAL; INFILTRATION INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is ROPIVACAINE HYDROCHLORIDE.
Product Information
| NDC | 00143-9263 |
|---|---|
| Product ID | 0143-9263_13db2593-44e9-44a1-95e5-a5010aa93423 |
| Associated GPIs | 69100070102008 |
| GCN Sequence Number | 028217 |
| GCN Sequence Number Description | ropivacaine HCl/PF VIAL 2 MG/ML INJECTION |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 46081 |
| HICL Sequence Number | 036674 |
| HICL Sequence Number Description | ROPIVACAINE HCL/PF |
| Brand/Generic | Generic |
| Proprietary Name | Ropivacaine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ropivacaine Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | EPIDURAL; INFILTRATION |
| Active Ingredient Strength | 2 |
| Active Ingredient Units | mg/mL |
| Substance Name | ROPIVACAINE HYDROCHLORIDE |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA214074 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00143-9263-10 (00143926310)
| NDC Package Code | 0143-9263-10 |
|---|---|
| Billing NDC | 00143926310 |
| Package | 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9263-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0143-9263-01) |
| Marketing Start Date | 2020-07-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |