Sensorcaine
- Product NDC
- 0404-9947
- 11-digit product format
- 004049947
- Labeler code
- 0404
- Product ID
- 0404-9947_6f90cc96-c462-455f-a92b-47ac6722d062
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupivacaine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- PERINEURAL
- Labeler
- Henry Schein, Inc.
- Application
- NDA018304
- Marketing category
- NDA
- Marketing start
- 2022-01-12
- Substance
- BUPIVACAINE HYDROCHLORIDE
- Active strength
- 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 |
|---|---|---|---|---|---|---|---|
| N018304-001 | SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | |
| N018304-002 | SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | |
| N018304-003 | SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | |
| N018304-004 | SENSORCAINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 |
| N018304-005 | SENSORCAINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N018304-001 | AP |
| N018304-002 | AP |
| N018304-003 | AP |
| N018304-004 | AP |
| N018304-005 | 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 | N018304-001 | SENSORCAINE | 0.25% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018304-002 | SENSORCAINE | 0.5% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018304-003 | SENSORCAINE | 0.75% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018304-004 | SENSORCAINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018304-005 | SENSORCAINE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N018304-001 | SENSORCAINE | 0.25% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018304-002 | SENSORCAINE | 0.5% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018304-003 | SENSORCAINE | 0.75% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018304-004 | SENSORCAINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018304-005 | SENSORCAINE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018304-001 | SENSORCAINE | 0.25% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018304-002 | SENSORCAINE | 0.5% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018304-003 | SENSORCAINE | 0.75% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018304-004 | SENSORCAINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018304-005 | SENSORCAINE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018304-001 | SENSORCAINE | 0.25% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018304-002 | SENSORCAINE | 0.5% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018304-003 | SENSORCAINE | 0.75% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018304-004 | SENSORCAINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018304-005 | SENSORCAINE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018304-001 | SENSORCAINE | 0.25% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018304-002 | SENSORCAINE | 0.5% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018304-003 | SENSORCAINE | 0.75% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018304-004 | SENSORCAINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018304-005 | SENSORCAINE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018304-001 | SENSORCAINE | 0.25% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018304-002 | SENSORCAINE | 0.5% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018304-003 | SENSORCAINE | 0.75% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018304-004 | SENSORCAINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018304-005 | SENSORCAINE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018304-001 | SENSORCAINE | 0.25% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018304-002 | SENSORCAINE | 0.5% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018304-003 | SENSORCAINE | 0.75% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018304-004 | SENSORCAINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018304-005 | SENSORCAINE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018304-001 | SENSORCAINE | 0.25% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018304-002 | SENSORCAINE | 0.5% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018304-003 | SENSORCAINE | 0.75% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018304-004 | SENSORCAINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018304-005 | SENSORCAINE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD | 1983-09-02 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N018304-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018304-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018304-003 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018304-004 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018304-005 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N018304-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018304-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018304-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018304-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018304-005 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018304-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018304-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018304-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018304-004 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018304-005 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018304-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018304-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018304-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018304-004 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018304-005 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018304-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018304-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018304-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018304-004 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018304-005 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018304-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018304-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018304-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018304-004 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018304-005 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018304-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018304-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018304-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018304-004 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018304-005 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018304-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018304-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018304-003 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018304-004 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018304-005 | AP | 1 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sensorcaine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUPIVACAINE HYDROCHLORIDE | 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 |
|---|---|
| 100201ad-6e4d-4e91-8b5c-621d0bf0dcc2 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0404-9947-50 | Sensorcaine | 1 in 1 BAG | INJECTION, SOLUTION | 1 | 5 | |
| 0404-9947-50 | Sensorcaine | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | 5 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| BUPIVACAINE HCl | BUPIVACAINE HCL | HF Acquisition Co LLC, DBA HealthFirst | e391f807-7699-6d82-e053-2a95a90ab641 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | 018304 NDA018304 |
| Sensorcaine | BUPIVACAINE HYDROCHLORIDE | Henry Schein, Inc. | 2046d833-2974-42fd-a29e-7fc1dc7166cc | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | 018304 NDA018304 |
| Sensorcaine | BUPIVACAINE HYDROCHLORIDE | Henry Schein, Inc. | 100201ad-6e4d-4e91-8b5c-621d0bf0dcc2 | 2025-11-07 | Warnings, Adverse reactions | 018304 NDA018304 0404-9947 |
| SENSORCAINE MPF | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Fresenius Kabi USA, LLC | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 2024-10-15 | Boxed warning, Warnings, Adverse reactions | 018304 NDA018304 |
| SENSORCAINE MPF | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Fresenius Kabi USA, LLC | dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175 | 2022-08-17 | Boxed warning, Warnings, Adverse reactions | 018304 NDA018304 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1012404 | BUPivacaine HCl 0.5 % Injectable Solution | PSN | 100201ad-6e4d-4e91-8b5c-621d0bf0dcc2 | 5 |
| 1012457 | Sensorcaine 0.5 % Injectable Solution | PSN | 100201ad-6e4d-4e91-8b5c-621d0bf0dcc2 | 5 |
| 1012457 | bupivacaine hydrochloride 5 MG/ML Injectable Solution [Sensorcaine] | SBD | 100201ad-6e4d-4e91-8b5c-621d0bf0dcc2 | 5 |
| 1012404 | bupivacaine hydrochloride 5 MG/ML Injectable Solution | SCD | 100201ad-6e4d-4e91-8b5c-621d0bf0dcc2 | 5 |
| 1012404 | bupivacaine hydrochloride 0.5 % Injectable Solution | SY | 100201ad-6e4d-4e91-8b5c-621d0bf0dcc2 | 5 |
| 1012457 | Sensorcaine 0.5 % Injectable Solution | SY | 100201ad-6e4d-4e91-8b5c-621d0bf0dcc2 | 5 |
| 1012457 | Sensorcaine 5 MG/ML Injectable Solution | SY | 100201ad-6e4d-4e91-8b5c-621d0bf0dcc2 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0404-9947-50 | 00404994750 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9947-50) / 50 mL in 1 VIAL, MULTI-DOSE | 2022-01-12 | 0000-00-00 | No | No | Current |