Application 012250
- Type
- NDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARBOCAINE | MEPIVACAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 1% | Yes | Yes |
| 002 | CARBOCAINE | MEPIVACAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 2% | Yes | Yes |
| 005 | CARBOCAINE | MEPIVACAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 1.5% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N012250-001 | CARBOCAINE | MEPIVACAINE HYDROCHLORIDE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N012250-002 | CARBOCAINE | MEPIVACAINE HYDROCHLORIDE | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N012250-005 | CARBOCAINE | MEPIVACAINE HYDROCHLORIDE | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 |
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| 2026-07 | N012250-001 | CARBOCAINE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N012250-002 | CARBOCAINE | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N012250-005 | CARBOCAINE | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N012250-001 | CARBOCAINE | 1% | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N012250-002 | CARBOCAINE | 2% | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N012250-005 | CARBOCAINE | 1.5% | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012250-001 | CARBOCAINE | 1% | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012250-002 | CARBOCAINE | 2% | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012250-005 | CARBOCAINE | 1.5% | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N012250-001 | CARBOCAINE | 1% | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N012250-002 | CARBOCAINE | 2% | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N012250-005 | CARBOCAINE | 1.5% | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012250-001 | CARBOCAINE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012250-002 | CARBOCAINE | 2% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012250-005 | CARBOCAINE | 1.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012250-001 | CARBOCAINE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012250-002 | CARBOCAINE | 2% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012250-005 | CARBOCAINE | 1.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012250-001 | CARBOCAINE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012250-002 | CARBOCAINE | 2% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012250-005 | CARBOCAINE | 1.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012250-001 | CARBOCAINE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012250-002 | CARBOCAINE | 2% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012250-005 | CARBOCAINE | 1.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012250-001 | CARBOCAINE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012250-002 | CARBOCAINE | 2% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012250-005 | CARBOCAINE | 1.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012250-001 | CARBOCAINE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012250-002 | CARBOCAINE | 2% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012250-005 | CARBOCAINE | 1.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N012250-001 | CARBOCAINE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N012250-002 | CARBOCAINE | 2% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N012250-005 | CARBOCAINE | 1.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012250-001 | CARBOCAINE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012250-002 | CARBOCAINE | 2% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012250-005 | CARBOCAINE | 1.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012250-001 | CARBOCAINE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012250-002 | CARBOCAINE | 2% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012250-005 | CARBOCAINE | 1.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012250-001 | CARBOCAINE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012250-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012250-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012250-005 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012250-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012250-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012250-005 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012250-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012250-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012250-005 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012250-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012250-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012250-005 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012250-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012250-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012250-005 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012250-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012250-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012250-005 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N012250-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N012250-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N012250-005 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012250-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012250-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012250-005 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012250-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012250-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012250-005 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012250-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012250-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012250-005 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N012250-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N012250-002 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N012250-005 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N012250-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N012250-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N012250-005 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N012250-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N012250-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N012250-005 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N012250-001 | AP | 1 | 4b0b4de00fa7… |
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 |
|---|---|---|---|---|---|---|
| Scandonest 3% Plain | MEPIVACAINE HYDROCHLORIDE | Septodont, Inc. | af6ff5f6-7221-421b-9b7c-8fcee4a47772 | 2025-05-29 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| MEPIVACAINE HYDROCHLORIDE | MEPIVACAINE HYDROCHLORIDE | Safco Dental Supply Co. | c4d45717-86c9-45bf-ba8e-2c255814ab50 | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Mepivacaine | MEPIVACAINE HYDROCHLORIDE | Novocol Pharmaceutical of Canada, Inc. | f58cb2c7-22a6-4341-8f9a-85c5628af797 | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Mepivacaine | MEPIVACAINE HYDROCHLORIDE | Darby Dental Supply, LLC | 5e81dae6-e55b-4d5e-9318-1d9395db052e | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Mepivacaine Hydrochloride | MEPIVACAINE HYDROCHLORIDE | Henry Schein Inc. | a3c2cddc-827b-4644-9060-e2fd2188b459 | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Carbocaine | MEPIVACAINE HYDROCHLORIDE | Septodont, Inc. | 1f2f9e40-e437-4124-97b7-df67dbafd154 | 2024-02-21 | Warnings, Adverse reactions | Carbocaine MEPIVACAINE HYDROCHLORIDE |
| Polocaine | MEPIVACAINE HYDROCHLORIDE | Novocol Pharmaceutical of Canada Inc. | eb7e2284-fe8d-46ad-b1d3-92ee2c6222bf | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Mepivacaine | MEPIVACAINE HYDROCHLORIDE | Benco Dental | c9a5a849-d010-4637-a66a-c26176401fbd | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Mepivacaine | MEPIVACAINE HYDROCHLORIDE | NDC, Inc. | 042010fb-7161-4336-b91f-5a25839ee644 | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Mepivacaine | MEPIVACAINE HYDROCHLORIDE | Patterson Dental Supply, Inc. | e8a3df4b-e918-4813-af3e-3c95f2c54250 | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Polocaine | MEPIVACAINE HYDROCHLORIDE | Dentsply Pharmaceutical | 25074a6a-7f67-4ad8-86e0-2afe23ec5d04 | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Polocaine-MPF | MEPIVACAINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | a27d0815-ae6b-4a21-a8f5-564c01e83814 | 2022-10-01 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-1036 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1036 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1036 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1036 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1036 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1038 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1038 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1038 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1038 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1038 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1038 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1041 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1041 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1041 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1041 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1041 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1067 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1067 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1067 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1067 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-1067 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-2047 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-2047 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-2047 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-2047 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |
| 0409-2047 | Carbocaine | Mepivacaine Hydrochloride | Hospira, Inc. | NDA | Current |