Prescription drug · NDA
Marcaine with Epinephrine NDC 0409-4208
bupivacaine hydrochloride and epinephrine · Bupivacaine hydrochloride 5 mg/mL; Epinephrine bitartrate .0091 mg/mL · Injection, Solution · Epidural, Intracaudal, Perineural · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-4208-10 | 00409420810 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-4208-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-4208-01)Marketed from Sep 26, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Marcaine with Epinephrine
- Generic name (nonproprietary)
- bupivacaine hydrochloride and epinephrine
- Active ingredients
- Bupivacaine hydrochloride — 5 mg/mLEpinephrine bitartrate — .0091 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural, Intracaudal, Perineural
- Labeler
- Hospira, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 016964
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Amides (Chemical structure)Catecholamines (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0409-4208_14ec85dc-0263-44d1-9267-66fa072cff8dSPL ID 14ec85dc-0263-44d1-9267-66fa072cff8dSPL set ID 93cf0914-de08-4ec6-8f8c-d663243b9958RxCUI 1012377, 1012381, 1012384, 1012388, 1672917, 1672919, 1673242, 1673243, 1867594, 1867596, 1867612, 1867614UNII 7TQO7W3VT8, 30Q7KI53AK
- Pharmacologic class
- Amide Local Anesthetic; Catecholamine; alpha-Adrenergic Agonist; beta-Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N400409420810followed by a unit qualifier and the quantityPackage 00409-4208-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ]. MARCAINE contains bupivacaine, an amide local anesthetic, and MARCAINE WITH EPINEPHRINE is a combination of bupivacaine, an amide local anesthetic, and epinephrine, an alpha and beta-adrenergic agonist. MARCAINE / MARCAINE WITH EPIN…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 016964
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Marcainebupivacaine hydrochloride | Bupivacaine hydrochloride 150 mg/30mL | Injection, SolutionEpidural, Intracaudal, Perineural | Hospira, Inc. | 0409-1530 |
| Marcaine with Epinephrinebupivacaine hydrochloride and epinephrine | Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate .0091 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Hospira, Inc. | 0409-1541 |
| Marcainebupivacine hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Henry Schein, Inc. | 0404-9768 |
| Marcainebupivacaine hydrochloride | Bupivacaine hydrochloride 75 mg/30mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Hospira, Inc. | 0409-7535 |
| Marcainebupivacaine hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Henry Schein, Inc. | 0404-9770 |
| Marcainebupivacaine hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionInfiltration, Perineural | Hospira, Inc. | 0409-1587 |
| Marcaine With Epinephrinebupivacaine hydrochloride and epinephrine bitartrate | Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate .0091 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Henry Schein, Inc. | 0404-9908 |
| Marcainebupivacaine hydrochloride | Bupivacaine hydrochloride 225 mg/30mL | Injection, SolutionEpidural, Retrobulbar | Hospira, Inc. | 0409-2253 |
| Marcainebupivacaine hydrochloride | Bupivacaine hydrochloride 50 mg/10mL | Injection, SolutionEpidural, Intracaudal, Perineural | Hospira, Inc. | 0409-5010 |
| Marcaine with Epinephrinebupivacaine hydrochloride and epinephrine | Bupivacaine hydrochloride 5 mg/mL; Epinephrine bitartrate .0091 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Hospira, Inc. | 0409-8126 |
| Marcainebupivacaine hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Henry Schein, Inc. | 0404-9779 |
| Marcaine with Epinephrinebupivacaine hydrochloride and epinephrine | Bupivacaine hydrochloride 5 mg/mL; Epinephrine bitartrate .0091 mg/mL | Injection, SolutionPerineural | Hospira, Inc. | 0409-6581 |
| Marcainebupivacaine hydrochloride | Bupivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Retrobulbar | Hospira, Inc. | 0409-1582 |
| Marcainebupivacaine hydrochloride | Bupivacaine hydrochloride 25 mg/10mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Hospira, Inc. | 0409-2510 |
| Marcaine with Epinephrinebupivacaine hydrochloride and epinephrine bitartrate | Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate .0091 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Hospira, Inc. | 0409-1746 |
| Marcaine with Epinephrinebupivacaine hydrochloride and epinephrine | Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate .0091 mg/mL | Injection, SolutionInfiltration, Perineural | Hospira, Inc. | 0409-3812 |
| Marcaine with Epinephrinebupivacaine hydrochloride and epinephrine bitartrate | Bupivacaine hydrochloride 5 mg/mL; Epinephrine bitartrate .0091 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Hospira, Inc. | 0409-1749 |
| Marcainebupivacaine hydrochloride | Bupivacaine hydrochloride 250 mg/50mL | Injection, SolutionPerineural | Hospira, Inc. | 0409-0525 |
| Marcaine with Epinephrinebupivacaine hydrochloride and epinephrine | Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate .0091 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Hospira, Inc. | 0409-5738 |
| Marcaine with Epinephrinebupivacaine hydrochloride and epinephrine bitartrate | Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate .0091 mg/mL | Injection, SolutionInfiltration, Perineural | Hospira, Inc. | 0409-1752 |
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