NDC 52584-560
Marcaine
Bupivacaine Hydrochloride
Marcaine is a Epidural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Bupivacaine Hydrochloride.
| Product ID | 52584-560_04862f0d-7ade-4f8c-b7d3-b66c42520e9e |
| NDC | 52584-560 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Marcaine |
| Generic Name | Bupivacaine Hydrochloride |
| Dosage Form | Injection, Solution |
| Route of Administration | EPIDURAL |
| Marketing Start Date | 2010-08-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA016964 |
| Labeler Name | General Injectables & Vaccines, Inc |
| Substance Name | BUPIVACAINE HYDROCHLORIDE |
| Active Ingredient Strength | 5 mg/mL |
| Pharm Classes | Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 52584-560-10
1 VIAL, SINGLE-DOSE in 1 BAG (52584-560-10) > 10 mL in 1 VIAL, SINGLE-DOSE
| Marketing Start Date | 2010-08-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 52584-560-10 [52584056010]
Marcaine INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA016964 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-08-01 |
| Inactivation Date | 2019-10-29 |
| Reactivation Date | 2020-03-03 |
NDC 52584-560-29 [52584056029]
Marcaine INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA016964 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-03-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| BUPIVACAINE HYDROCHLORIDE | 5 mg/mL |
OpenFDA Data
| SPL SET ID: | 8db7c501-993a-444d-a819-d1f9df1d7b62 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Amide Local Anesthetic [EPC]
- Amides [CS]
- Local Anesthesia [PE]
NDC Crossover Matching brand name "Marcaine" or generic name "Bupivacaine Hydrochloride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0362-0557 | Marcaine | bupivacaine hydrochloride and epinephrine bitartrate |
| 0404-9906 | Marcaine | Bupivacaine Hydrochloride |
| 0404-9907 | Marcaine | Bupivacaine Hydrochloride |
| 31382-557 | Marcaine | Marcaine |
| 52584-560 | Marcaine | Marcaine |
| 52584-559 | Marcaine | Marcaine |
| 0409-1560 | Marcaine | Marcaine |
| 0409-1587 | Marcaine | Marcaine |
| 0409-1610 | Marcaine | Marcaine |
| 0409-1582 | Marcaine | Marcaine |
| 0409-1559 | Marcaine | Marcaine |
| 0143-9328 | Bupivacaine Hydrochloride | Bupivacaine Hydrochloride |
| 0143-9329 | Bupivacaine Hydrochloride | Bupivacaine Hydrochloride |
| 0143-9330 | Bupivacaine Hydrochloride | Bupivacaine Hydrochloride |
| 0143-9331 | Bupivacaine Hydrochloride | Bupivacaine Hydrochloride |
| 0143-9332 | Bupivacaine Hydrochloride | Bupivacaine Hydrochloride |
| 0143-9333 | Bupivacaine Hydrochloride | Bupivacaine Hydrochloride |
| 0143-9334 | Bupivacaine Hydrochloride | Bupivacaine Hydrochloride |
| 0143-9335 | Bupivacaine Hydrochloride | Bupivacaine Hydrochloride |
| 0404-9826 | Bupivacaine Hydrochloride | Bupivacaine Hydrochloride |
| 0404-9827 | Bupivacaine Hydrochloride | Bupivacaine Hydrochloride |
| 0409-1159 | BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride |
| 0409-1160 | Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE |
| 0409-1162 | BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride |
| 0404-9945 | Sensorcaine | Bupivacaine Hydrochloride |
| 0404-9947 | Sensorcaine | Bupivacaine Hydrochloride |
| 0404-9946 | Sensorcaine MPF | bupivacaine hydrochloride |
Trademark Results [Marcaine]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MARCAINE 72330306 0894463 Live/Registered |
STERLING DRUG INC. 1969-06-17 |
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