Application 016964
- Type
- NDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MARCAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.25% | Yes | Yes |
| 004 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | INJECTABLE;INJECTION | 0.25%;0.0091MG/ML | Yes | Yes |
| 005 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.5% | Yes | Yes |
| 006 | MARCAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.5% | Yes | Yes |
| 007 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | INJECTABLE;INJECTION | 0.5%;0.0091MG/ML | Yes | Yes |
| 008 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | INJECTABLE;INJECTION | 0.5%;0.0091MG/ML | Yes | Yes |
| 009 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.75% | Yes | Yes |
| 010 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | INJECTABLE;INJECTION | 0.75%;0.0091MG/ML | Yes | Yes |
| 012 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.25% | Yes | Yes |
| 013 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | INJECTABLE;INJECTION | 0.25%;0.0091MG/ML | Yes | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N016964-001 | MARCAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-004 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-005 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-006 | MARCAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-007 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-008 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-009 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.75% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-010 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-012 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-013 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N016964-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-004 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-005 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-006 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-007 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-008 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-009 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-010 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-012 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-013 | AP | 1 | 84e616aacf4f… |
| 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… |
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 |
| 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 0409-1755 |
| 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 0409-8126 0409-5738 0409-3812 0409-4208 0409-6581 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-1755 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Hospira, Inc. | NDA | Current |
| 0409-3812 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | Hospira, Inc. | NDA | Current |
| 0409-3812 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | Hospira, Inc. | NDA | Current |
| 0409-4208 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | Hospira, Inc. | NDA | Current |
| 0409-5738 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | Hospira, Inc. | NDA | Current |
| 0409-5738 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | Hospira, Inc. | NDA | Current |
| 0409-6581 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | Hospira, Inc. | NDA | Current |
| 0409-8126 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | Hospira, Inc. | NDA | Current |
| 0409-8126 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | Hospira, Inc. | NDA | Current |
| 49836-000 | P-Care 100MX | bupivacaine hydrochloride, lidocaine hydrochloride, sodium chloride, povidone-iodine, isopropyl alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-000 | P-Care 100MX | bupivacaine hydrochloride, lidocaine hydrochloride, sodium chloride, povidone-iodine, isopropyl alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-000 | P-Care 100MX | bupivacaine hydrochloride, lidocaine hydrochloride, sodium chloride, povidone-iodine, isopropyl alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-001 | P-Care M | Bupivacaine Hydrochloride, Sodium Chloride, Povidone-Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-001 | P-Care M | Bupivacaine Hydrochloride, Sodium Chloride, Povidone-Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-001 | P-Care M | Bupivacaine Hydrochloride, Sodium Chloride, Povidone-Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-002 | P-Care MG | Bupivacaine Hydrochloride, Sodium Chloride, Povidone-Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-002 | P-Care MG | Bupivacaine Hydrochloride, Sodium Chloride, Povidone-Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-002 | P-Care MG | Bupivacaine Hydrochloride, Sodium Chloride, Povidone-Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 52584-559 | Marcaine | Bupivacaine Hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-559 | Marcaine | Bupivacaine Hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-559 | Marcaine | Bupivacaine Hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-559 | Marcaine | Bupivacaine Hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-559 | Marcaine | Bupivacaine Hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-559 | Marcaine | Bupivacaine Hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-559 | Marcaine | Bupivacaine Hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-560 | Marcaine | Bupivacaine Hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-560 | Marcaine | Bupivacaine Hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-560 | Marcaine | Bupivacaine Hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-560 | Marcaine | Bupivacaine Hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-560 | Marcaine | Bupivacaine Hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-560 | Marcaine | Bupivacaine Hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-560 | Marcaine | Bupivacaine Hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-560 | Marcaine | Bupivacaine Hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-560 | Marcaine | Bupivacaine Hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-746 | MARCAINE WITH EPINEPHRINE | bupivacaine hydrochloride and epinephrine bitartrate | General Injectables & Vaccines, Inc. | NDA | Current |
| 52584-746 | MARCAINE WITH EPINEPHRINE | bupivacaine hydrochloride and epinephrine bitartrate | General Injectables & Vaccines, Inc. | NDA | Current |
| 53225-3125 | ReadySharp-A | Lidocaine Hydrochloride and Bupivacaine Hydrochloride | Terrain Pharmaceuticals | NDA | Current |
| 53225-3230 | ReadySharp-K | Lidocaine Hydrochloride, Bupivacaine Hydrochloride, and Triamcinolone Acetonide | Terrain Pharmaceuticals | NDA | Current |
| 53225-3335 | ReadySharp-P40 | Lidocaine Hydrochloride, Bupivacaine Hydrochloride, and Methylprednisolone Acetate | Terrain Pharmaceuticals | NDA | Current |
| 53225-3440 | ReadySharp-P80 | Lidocaine Hydrochloride, Bupivacaine Hydrochloride, and Methylprednisolone Acetate | Terrain Pharmaceuticals | NDA | Current |
| 53225-4000 | ReadySharp Anesthetics plus Ketorolac | Lidocaine Hydrochloride, Bupivacaine Hydrochloride, and Ketorolac Tromethamine | Terrain Pharmaceuticals | NDA | Current |
| 53225-4105 | ReadySharp Anesthetics plus Betamethasone | Lidocaine Hydrochloride, Bupivacaine Hydrochloride, and Betamethasone Sodium Phosphate and Betamethasone Acetate | Terrain Pharmaceuticals | NDA | Current |
| 53225-4210 | ReadySharp Anesthetics plus Dexamethasone | Lidocaine Hydrochloride, Bupivacaine Hydrochloride, and Dexamethasone Sodium Phosphate | Terrain Pharmaceuticals | NDA | Current |
| 53225-4315 | ReadySharp Anesthetics plus MethylPrednisolone 80 | Lidocaine Hydrochloride, Bupivacaine Hydrochloride, and Methylprednisolone Acetate | Terrain Pharmaceuticals | NDA | Current |
| 63187-352 | Physicians EZ Use M-pred | METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE | Proficient Rx LP | NDA | Current |
| 70529-005 | Durapren 0.5% | BUPIVACAINE HYDROCHLORIDE | IT3 Medical LLC | NDA | Current |
| 70529-005 | Durapren 0.5% | BUPIVACAINE HYDROCHLORIDE | IT3 Medical LLC | NDA | Current |
| 70529-005 | Durapren 0.5% | BUPIVACAINE HYDROCHLORIDE | IT3 Medical LLC | NDA | Current |
| 70529-007 | Durapren 0.75% | BUPIVACAINE HYDROCHLORIDE | IT3 Medical LLC | NDA | Current |
| 70529-007 | Durapren 0.75% | BUPIVACAINE HYDROCHLORIDE | IT3 Medical LLC | NDA | Current |
| 70529-007 | Durapren 0.75% | BUPIVACAINE HYDROCHLORIDE | IT3 Medical LLC | NDA | Current |