Marcaine
- Product NDC
- 0404-9770
- 11-digit product format
- 004049770
- Labeler code
- 0404
- Product ID
- 0404-9770_dba40c2a-6967-4b86-a56d-e933f23f4ea3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupivacaine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
- Labeler
- Henry Schein, Inc.
- Application
- NDA016964
- Marketing category
- NDA
- Marketing start
- 2025-12-02
- Substance
- BUPIVACAINE HYDROCHLORIDE
- Active strength
- 2.5 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N016964-001 | MARCAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-004 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-005 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-006 | MARCAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-007 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-008 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-009 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-010 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-012 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-013 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N016964-001 | AP |
| N016964-004 | AP |
| N016964-005 | AP |
| N016964-006 | AP |
| N016964-007 | AP |
| N016964-008 | AP |
| N016964-009 | AP |
| N016964-010 | AP |
| N016964-012 | AP |
| N016964-013 | AP |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N016964-001 | MARCAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-004 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-005 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-006 | MARCAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-007 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-008 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-009 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.75% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-010 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-012 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-013 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-001 | MARCAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-004 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-005 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-006 | MARCAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-007 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-008 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-009 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.75% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-010 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-012 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-013 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-001 | MARCAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-004 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-005 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-006 | MARCAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-007 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-008 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-009 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.75% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-010 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-012 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-013 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-001 | MARCAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-004 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-005 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-006 | MARCAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-007 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-008 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-009 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.75% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-010 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-012 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-013 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N016964-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-004 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-005 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-006 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-007 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-008 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-009 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-010 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-012 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-013 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-005 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-006 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-007 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-008 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-009 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-010 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-012 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-013 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-004 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-005 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-006 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-007 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-008 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-009 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-010 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-012 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-013 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-004 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-005 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-006 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-007 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-008 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-009 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-010 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-012 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N016964-013 | AP | 1 | 6a471c1ec25d… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Marcaine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUPIVACAINE HYDROCHLORIDE | 2.5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7TQO7W3VT8 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 562f4499-f3b7-4d9e-b022-61172176c883 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cbf85893-59ef-423f-87d4-a573c000a8b9 | Product name | 8 | 20250731 |
| 5dad6767-dcd1-b0da-8727-7f3f7bc3a435 | Product name | 2 | 20250303 |
| e3a99641-4540-4894-9108-00cab3c57b7e | Product name | 1 | 20211207 |
| 5da98533-f072-406b-9e1b-6ac19eca9926 | Product name | 1 | 20210622 |
| 306b993e-3140-4823-ad5e-88b708f9d2ac | Product name | 1 | 20210510 |
| a831e694-3663-4a83-82be-6c309429f750 | Product name | 2 | 20200608 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0404-9770-10 | Marcaine | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | 1 | |
| 0404-9770-10 | Marcaine | 1 in 1 BAG | INJECTION, SOLUTION | 1 | 1 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Marcaine | BUPIVACAINE HYDROCHLORIDE | Henry Schein, Inc. | 562f4499-f3b7-4d9e-b022-61172176c883 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 016964 NDA016964 0404-9770 |
| Marcaine | BUPIVACAINE HYDROCHLORIDE | Henry Schein, Inc. | 2c6f9b85-e783-4ad4-a804-a0ff1a32ec2c | 2026-06-24 | Warnings, Adverse reactions | 016964 NDA016964 |
| Marcaine | BUPIVACAINE HYDROCHLORIDE | Hospira, Inc. | 67578b56-7540-487e-1fba-481255620e78 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 016964 NDA016964 |
| MARCAINE WITH EPINEPHRINE | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Henry Schein, Inc. | d0d51133-882c-4f9e-ba1c-f037226305a1 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | 016964 NDA016964 |
| Marcaine | BUPIVACINE HYDROCHLORIDE | Henry Schein, Inc. | 7d94e8e0-0d1e-4af3-973a-a480d7d51737 | 2026-01-26 | Warnings, Adverse reactions | 016964 NDA016964 |
| Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | Hospira, Inc. | 93cf0914-de08-4ec6-8f8c-d663243b9958 | 2024-02-02 | Boxed warning, Warnings, Adverse reactions | 016964 NDA016964 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1725078 | BUPivacaine HCl 0.25 % in 10 ML Injection | PSN | 562f4499-f3b7-4d9e-b022-61172176c883 | 1 |
| 1725079 | Marcaine 0.25 % in 10 ML Injection | PSN | 562f4499-f3b7-4d9e-b022-61172176c883 | 1 |
| 1725079 | 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine] | SBD | 562f4499-f3b7-4d9e-b022-61172176c883 | 1 |
| 1725078 | 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | 562f4499-f3b7-4d9e-b022-61172176c883 | 1 |
| 1725079 | 10 ML Marcaine 2.5 MG/ML Injection | SY | 562f4499-f3b7-4d9e-b022-61172176c883 | 1 |
| 1725078 | bupivacaine HCl 0.25 % in 10 ML Injection | SY | 562f4499-f3b7-4d9e-b022-61172176c883 | 1 |
| 1725079 | Marcaine 0.25 % in 10 ML Injection | SY | 562f4499-f3b7-4d9e-b022-61172176c883 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 0404-9770-10 | 00404977010 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9770-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 2025-12-02 | No | No | Current |