SENSORCAINE
- Product NDC
- 63323-464
- 11-digit product format
- 633230464
- Labeler code
- 63323
- Product ID
- 63323-464_13a48007-3784-46f2-bd4d-da1004186b81
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPIVACAINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA018304
- Marketing category
- NDA
- Marketing start
- 2010-11-19
- 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 |
|---|---|---|---|---|---|---|---|
| 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
- Brand name suffix
- MPF
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUPIVACAINE HYDROCHLORIDE | 2.5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7TQO7W3VT8 | Internal UNII lookup |
| 30Q7KI53AK | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1672917 | Internal RxNorm lookup |
| 1672919 | Internal RxNorm lookup |
| 1673296 | Internal RxNorm lookup |
| 1673298 | Internal RxNorm lookup |
| 1724880 | Internal RxNorm lookup |
| 1724881 | Internal RxNorm lookup |
| 1724884 | Internal RxNorm lookup |
| 1724885 | Internal RxNorm lookup |
| 1725078 | Internal RxNorm lookup |
| 1725082 | Internal RxNorm lookup |
| 1725175 | Internal RxNorm lookup |
| 1725177 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-464-02 | SENSORCAINEMPF | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | 10 | |
| 63323-464-03 | SENSORCAINEMPF | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | 10 | |
| 63323-464-31 | SENSORCAINEMPF | 5 in 1 BOX | INJECTION, SOLUTION | 5 | 10 | |
| 63323-464-37 | SENSORCAINEMPF | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 10 | |
| 63323-464-01 | SensorcaineMPF | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | 7 | |
| 63323-464-17 | SensorcaineMPF | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 7 | |
| 63323-464-08 | SENSORCAINEMPF | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | 1 | |
| 63323-464-09 | SENSORCAINEMPF | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | 1 | |
| 63323-464-38 | SENSORCAINEMPF | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 1 | |
| 63323-464-39 | SENSORCAINEMPF | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-464-01 | ML - Milliliter | 63323-464 | a95009d7-4c76-43d9-a031-32de3733f023 | 1 | 2021-09-07 |
| 63323-464-02 | ML - Milliliter | 63323-464 | ed5d75df-0557-4de0-be0d-b650577eb9cd | 1 | 2022-02-07 |
| 63323-464-08 | ML - Milliliter | 63323-464 | b9775b1b-7b08-44ff-a98c-ff02d3683946 | 1 | 2025-01-14 |
| 63323-464-09 | ML - Milliliter | 63323-464 | 7fec3893-88a9-4e8e-93c9-ff52085ce489 | 1 | 2024-11-05 |
| 63323-464-17 | ML - Milliliter | 63323-464 | 018101d1-b391-4d43-a136-957d34adf595 | 1 | 2012-07-24 |
| 63323-464-31 | ML - Milliliter | 63323-464 | fd4dff38-e949-491f-920d-8ed9e60e7ac8 | 1 | 2012-07-24 |
| 63323-464-33 | ML - Milliliter | 63323-464 | f9592b4f-7114-4d9a-a869-a2d296abbd2d | 1 | 2012-07-24 |
| 63323-464-37 | ML - Milliliter | 63323-464 | 77835e45-e7a7-46f2-888e-7c68cad0a54c | 1 | 2012-07-24 |
| 63323-464-38 | ML - Milliliter | 63323-464 | 8d957fa6-2077-461b-b74f-6e6b6839b4e2 | 1 | 2025-01-14 |
| 63323-464-39 | ML - Milliliter | 63323-464 | 3e1e097f-d34f-4a38-90d4-c2c7a9797684 | 1 | 2024-11-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-464 | SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 10 | Current NDC, Legacy NDC, 4 package rows | 20241031_eb6d8fee-def4-4c96-9972-695e8cea8ea8.zip |
| 63323-464 | SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ] | 7 | Current NDC, Legacy NDC, 2 package rows | 20230630_e700eb7b-8b14-49c9-96b2-331f18776e45.zip |
| 63323-464 | SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20241012_dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175.zip |
| 63323-464 | SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20241222_b6bfc04a-1868-4630-9ca1-8c027af97ce3.zip |
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 |
| SENSORCAINE MPF | BUPIVACAINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | b6bfc04a-1868-4630-9ca1-8c027af97ce3 | 2024-11-18 | Boxed warning, Warnings, Adverse reactions | 63323-464 |
| 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 63323-464 |
| Sensorcaine MPF | BUPIVACAINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | e700eb7b-8b14-49c9-96b2-331f18776e45 | 2023-05-12 | Boxed warning, Warnings, Adverse reactions | 63323-464 |
| 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 63323-464 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1725078 | BUPivacaine HCl 0.25 % in 10 ML Injection | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1725082 | BUPivacaine HCl 0.25 % in 30 ML Injection | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012396 | BUPivacaine HCl 0.25 % Injectable Solution | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1672917 | BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 10 ML Injection | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1672919 | BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 30 ML Injection | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1724880 | BUPivacaine HCl 0.5 % in 10 ML Injection | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1724884 | BUPivacaine HCl 0.5 % in 30 ML Injection | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012404 | BUPivacaine HCl 0.5 % Injectable Solution | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012391 | BUPivacaine HCl 0.75 % / EPINEPHrine 1:200,000 in 30 ML Injection | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1725175 | Sensorcaine 0.25 % in 10 ML Injection | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1725177 | Sensorcaine 0.25 % in 30 ML Injection | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012455 | Sensorcaine 0.25 % Injectable Solution | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1673298 | Sensorcaine 0.5 % / EPINEPHrine 1:200,000 in 30 ML Injection | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1724881 | Sensorcaine 0.5 % in 10 ML Injection | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1724885 | Sensorcaine 0.5 % in 30 ML Injection | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012457 | Sensorcaine 0.5 % Injectable Solution | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012421 | Sensorcaine 0.75 % / EPINEPHrine 1:200,000 in 30 ML Injection | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1673296 | Sensorcaine 5 % / EPINEPHrine 1:200,000 in 10 ML Injection | PSN | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1725175 | 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine] | SBD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1673296 | 10 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection [Sensorcaine with Epinephrine] | SBD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1724881 | 10 ML bupivacaine hydrochloride 5 MG/ML Injection [Sensorcaine] | SBD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1725177 | 30 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine] | SBD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1673298 | 30 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection [Sensorcaine with Epinephrine] | SBD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1724885 | 30 ML bupivacaine hydrochloride 5 MG/ML Injection [Sensorcaine] | SBD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012421 | 30 ML bupivacaine hydrochloride 7.5 MG/ML / epinephrine 0.005 MG/ML Injection [Sensorcaine with Epinephrine] | SBD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012455 | bupivacaine hydrochloride 2.5 MG/ML Injectable Solution [Sensorcaine] | SBD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012457 | bupivacaine hydrochloride 5 MG/ML Injectable Solution [Sensorcaine] | SBD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1725078 | 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1672917 | 10 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection | SCD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1724880 | 10 ML bupivacaine hydrochloride 5 MG/ML Injection | SCD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1725082 | 30 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1672919 | 30 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection | SCD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1724884 | 30 ML bupivacaine hydrochloride 5 MG/ML Injection | SCD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012391 | 30 ML bupivacaine hydrochloride 7.5 MG/ML / epinephrine 0.005 MG/ML Injection | SCD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012396 | bupivacaine hydrochloride 2.5 MG/ML Injectable Solution | SCD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012404 | bupivacaine hydrochloride 5 MG/ML Injectable Solution | SCD | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1725175 | 10 ML Sensorcaine 2.5 MG/ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1724881 | 10 ML Sensorcaine 5 MG/ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1725177 | 30 ML Sensorcaine 2.5 MG/ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1724885 | 30 ML Sensorcaine 5 MG/ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1725078 | bupivacaine HCl 0.25 % in 10 ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1725082 | bupivacaine HCl 0.25 % per 30 ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1672917 | bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 10 ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1672919 | bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 30 ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1724880 | bupivacaine HCl 0.5 % in 10 ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1724884 | bupivacaine HCl 0.5 % in 30 ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012391 | bupivacaine HCl 0.75 % / epinephrine (as epinephrine bitartrate) 1:200,000 per 30 ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012396 | bupivacaine hydrochloride 0.25 % Injectable Solution | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012404 | bupivacaine hydrochloride 0.5 % Injectable Solution | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012455 | Sensorcaine 0.25 % Injectable Solution | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1673298 | Sensorcaine 0.5 % / epinephrine (as bitratrate) 1:200,000 in 30 mL Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012457 | Sensorcaine 0.5 % Injectable Solution | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012455 | Sensorcaine 2.5 MG/ML Injectable Solution | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1673296 | Sensorcaine 5 % / EPINEPHrine 1:200,000 per 10 ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012457 | Sensorcaine 5 MG/ML Injectable Solution | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012421 | Sensorcaine with Epinephrine 0.75 % / 1:200,000 (bupivacaine hydrochloride / epinephrine (as epinephrine bitartrate) ) per 30 ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1725175 | Sensorcaine-MPF 0.25 % in 10 ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1725177 | Sensorcaine-MPF 0.25 % in 30 ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1724881 | Sensorcaine-MPF 0.5 % in 10 ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1724885 | Sensorcaine-MPF 0.5 % in 30 ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1012421 | Sensorcaine-MPF 0.75 % / epinephrine 1:200,000 per 30 ML Injection | SY | eb6d8fee-def4-4c96-9972-695e8cea8ea8 | 10 |
| 1725078 | BUPivacaine HCl 0.25 % in 10 ML Injection | PSN | e700eb7b-8b14-49c9-96b2-331f18776e45 | 7 |
| 1724880 | BUPivacaine HCl 0.5 % in 10 ML Injection | PSN | e700eb7b-8b14-49c9-96b2-331f18776e45 | 7 |
| 1725175 | Sensorcaine 0.25 % in 10 ML Injection | PSN | e700eb7b-8b14-49c9-96b2-331f18776e45 | 7 |
| 1724881 | Sensorcaine 0.5 % in 10 ML Injection | PSN | e700eb7b-8b14-49c9-96b2-331f18776e45 | 7 |
| 1725175 | 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine] | SBD | e700eb7b-8b14-49c9-96b2-331f18776e45 | 7 |
| 1724881 | 10 ML bupivacaine hydrochloride 5 MG/ML Injection [Sensorcaine] | SBD | e700eb7b-8b14-49c9-96b2-331f18776e45 | 7 |
| 1725078 | 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | e700eb7b-8b14-49c9-96b2-331f18776e45 | 7 |
| 1724880 | 10 ML bupivacaine hydrochloride 5 MG/ML Injection | SCD | e700eb7b-8b14-49c9-96b2-331f18776e45 | 7 |
| 1725175 | 10 ML Sensorcaine 2.5 MG/ML Injection | SY | e700eb7b-8b14-49c9-96b2-331f18776e45 | 7 |
| 1724881 | 10 ML Sensorcaine 5 MG/ML Injection | SY | e700eb7b-8b14-49c9-96b2-331f18776e45 | 7 |
| 1725078 | bupivacaine HCl 0.25 % in 10 ML Injection | SY | e700eb7b-8b14-49c9-96b2-331f18776e45 | 7 |
| 1724880 | bupivacaine HCl 0.5 % in 10 ML Injection | SY | e700eb7b-8b14-49c9-96b2-331f18776e45 | 7 |
| 1725175 | Sensorcaine-MPF 0.25 % in 10 ML Injection | SY | e700eb7b-8b14-49c9-96b2-331f18776e45 | 7 |
| 1724881 | Sensorcaine-MPF 0.5 % in 10 ML Injection | SY | e700eb7b-8b14-49c9-96b2-331f18776e45 | 7 |
| 1725078 | BUPivacaine HCl 0.25 % in 10 ML Injection | PSN | dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175 | 1 |
| 1725078 | BUPivacaine HCl 0.25 % in 10 ML Injection | PSN | b6bfc04a-1868-4630-9ca1-8c027af97ce3 | 1 |
| 1725082 | BUPivacaine HCl 0.25 % in 30 ML Injection | PSN | b6bfc04a-1868-4630-9ca1-8c027af97ce3 | 1 |
| 1725082 | BUPivacaine HCl 0.25 % in 30 ML Injection | PSN | dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175 | 1 |
| 1672917 | BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 10 ML Injection | PSN | dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63323-464-01 | 63323046401 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | Historical | ||||
| 63323-464-02 | 63323046402 | 30 mL in 1 VIAL, SINGLE-DOSE | 30 ml | Historical | ||||
| 63323-464-03 | 63323046403 | 30 mL in 1 VIAL, SINGLE-DOSE | 30 ml | Historical | ||||
| 63323-464-08 | 63323046408 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | Historical | ||||
| 63323-464-09 | 63323046409 | 30 mL in 1 VIAL, SINGLE-DOSE | 30 ml | Historical | ||||
| 63323-464-17 | 63323046417 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-464-17) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-464-01) | 2010-11-19 | 0000-00-00 | No | No | Current | |
| 63323-464-31 | 63323046431 | 5 VIAL, SINGLE-DOSE in 1 BOX (63323-464-31) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-464-03) | 2010-11-19 | 0000-00-00 | No | No | Current | |
| 63323-464-37 | 63323046437 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-464-37) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-464-02) | 2010-11-19 | 0000-00-00 | No | No | Current | |
| 63323-464-38 | 63323046438 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-464-38) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-464-08) | 2022-07-29 | No | No | Current | ||
| 63323-464-39 | 63323046439 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-464-39) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-464-09) | 2022-07-29 | No | No | Current |