Bupivacaine Hydrochloride
- Product NDC
- 0409-1159
- 11-digit product format
- 004091159
- Labeler code
- 0409
- Product ID
- 0409-1159_6e442bfd-d3da-4913-8585-ce3485644364
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPIVACAINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
- Labeler
- Hospira, Inc.
- Application
- ANDA070583
- Marketing category
- ANDA
- Marketing start
- 2005-05-06
- 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A070583-001 | BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A070583-001 | 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 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A070583-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 1987-02-17 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A070583-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A070583-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070583-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A070583-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070583-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070583-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070583-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070583-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070583-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070583-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A070583-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070583-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070583-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070583-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A070583-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A070583-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A070583-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A070583-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A070583-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A070583-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A070583-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A070583-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A070583-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A070583-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A070583-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A070583-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A070583-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A070583-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A070583-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A070583-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A070583-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A070583-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A070583-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A070583-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A070583-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A070583-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A070583-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A070583-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A070583-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A070583-001 | AP | 1 | e64feba35796… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bupivacaine Hydrochloride
- 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 |
| 30Q7KI53AK | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1012377 | Internal RxNorm lookup |
| 1012384 | Internal RxNorm lookup |
| 1012396 | Internal RxNorm lookup |
| 1012404 | Internal RxNorm lookup |
| 1672917 | Internal RxNorm lookup |
| 1672919 | Internal RxNorm lookup |
| 1724786 | Internal RxNorm lookup |
| 1724787 | Internal RxNorm lookup |
| 1724880 | Internal RxNorm lookup |
| 1724884 | Internal RxNorm lookup |
| 1725078 | Internal RxNorm lookup |
| 1725082 | Internal RxNorm lookup |
| 1867594 | Internal RxNorm lookup |
| 1867596 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 02a845c3-4521-4926-e397-25ab536e7cf6 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0409-1159-01 | Bupivacaine Hydrochloride | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 39 | |
| 0409-1159-02 | Bupivacaine Hydrochloride | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 39 | |
| 0409-1159-18 | Bupivacaine Hydrochloride | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | 39 | |
| 0409-1159-19 | Bupivacaine Hydrochloride | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | 39 | |
| 0409-1159-09 | BUPIVACAINE HYDROCHLORIDE | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | 21 | |
| 0409-1159-10 | BUPIVACAINE HYDROCHLORIDE | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 21 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0409-1159-01 | ML - Milliliter | 0409-1159 | bc51d982-260e-4258-86a1-c52f46081135 | 1 | 2012-07-24 |
| 0409-1159-02 | ML - Milliliter | 0409-1159 | f8b40b90-f53d-4bc9-9cc1-c5dc34e8bb8d | 1 | 2012-07-24 |
| 0409-1159-09 | ML - Milliliter | 0409-1159 | aa96449c-5a7d-442a-b44b-aa201f806901 | 1 | 2016-03-04 |
| 0409-1159-10 | ML - Milliliter | 0409-1159 | 6d1dcaab-16e0-4b08-a74a-620fcaf24a86 | 1 | 2016-01-13 |
| 0409-1159-18 | ML - Milliliter | 0409-1159 | d2fac562-954a-4e5d-bb09-73862ad68531 | 1 | 2017-06-15 |
| 0409-1159-19 | ML - Milliliter | 0409-1159 | aedb9e8d-6147-480a-8fd8-849cbd6add32 | 1 | 2017-05-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0409-1159 | BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.] | 38 | Current NDC, Legacy NDC, 4 package rows | 20241017_02a845c3-4521-4926-e397-25ab536e7cf6.zip |
| 0409-1159 | BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 19 | Current NDC, Legacy NDC, 2 package rows | 20241105_bb44c7e1-d911-4788-908f-09b7b271969b.zip |
| 0409-1159 | KETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] | 13 | Current NDC, Legacy NDC | 20241008_35ffe071-8bc1-4c88-8c85-645847acf169.zip |
| 0409-1159 | DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] | 11 | Current NDC, Legacy NDC | 20241008_cdd72141-10b6-48c6-85be-5b1294c8539c.zip |
| 0409-1159 | MARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] | 11 | Current NDC, Legacy NDC | 20241008_9a6a3871-4e02-47f9-a20e-a256b3f3c498.zip |
| 0409-1159 | DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, MARICAINE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] | 10 | Current NDC, Legacy NDC | 20241008_d3fd1d51-7749-4e1e-a8b5-8a151392f66d.zip |
| 0409-1159 | DYURAL 40 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] | 10 | Current NDC, Legacy NDC | 20241008_151ae26c-bd4e-4582-b67a-7b5baf466953.zip |
| 0409-1159 | DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] | 10 | Current NDC, Legacy NDC | 20241008_e9f7f923-e7f9-4c52-b56d-914d800c1acf.zip |
| 0409-1159 | MARLIDO 25 KIT (LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] | 10 | Current NDC, Legacy NDC | 20241008_1fe460e7-208d-410e-84c5-cd63005cff47.zip |
| 0409-1159 | MARBETA 25 KIT (BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] | 9 | Current NDC, Legacy NDC | 20241013_1c157964-1977-4617-9f01-76ca01fb0f8f.zip |
| 0409-1159 | MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] | 9 | Current NDC, Legacy NDC | 20241008_94472ddb-ae1d-4a11-a673-81254d562e6b.zip |
| 0409-1159 | DYURAL 80-LM (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] | 5 | Current NDC, Legacy NDC | 20241008_c4071146-7d89-4c3a-9278-389d801cf66d.zip |
| 0409-1159 | DYURAL 40 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC | 20250102_01ca16de-ab2e-4e19-e063-6394a90a0510.zip |
| 0409-1159 | DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC | 20250102_01ca2f07-9c84-e418-e063-6294a90ac760.zip |
| 0409-1159 | DYURAL 80-LM (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC | 20250102_01ca7a2d-e8cb-c063-e063-6294a90ae7f9.zip |
| 0409-1159 | KETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC | 20250102_fb81d452-30e0-f019-e053-6394a90a7634.zip |
| 0409-1159 | BLT-25 KIT (BUPIVACAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE, TRIAMCINOLONE ACETONIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] | 1 | Current NDC, Legacy NDC | 20240913_87307801-d970-41cf-ad1e-d89b0ff8549f.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 Hydrochloride | BUPIVACAINE HYDROCHLORIDE | Sportpharm LLC | 6f9ebeef-350a-495e-a0bf-c335ab48bf1c | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | 070583 ANDA070583 |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | Cardinal Health 107, LLC | 8f8f4ece-de78-4c13-8d9f-c3bb7053019d | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | 070583 ANDA070583 |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | Hospira, Inc. | bb44c7e1-d911-4788-908f-09b7b271969b | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | 070583 ANDA070583 0409-1159 |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | Hospira, Inc. | 02a845c3-4521-4926-e397-25ab536e7cf6 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | 070583 ANDA070583 0409-1159 |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | ProPharma Distribution | 3f7ab295-6429-4760-e063-6294a90a781f | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 070583 ANDA070583 |
| BUPIVICAINE HYDROCHLORIDE | BUPIVICAINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 99857946-6084-1bbd-e053-2a95a90af58c | 2020-10-06 | Warnings, Adverse reactions | 070583 ANDA070583 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1867594 | BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 10 ML Injection | PSN | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1867596 | BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 30 ML Injection | PSN | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1012377 | BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 Injectable Solution | PSN | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1725078 | BUPivacaine HCl 0.25 % in 10 ML Injection | PSN | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1725082 | BUPivacaine HCl 0.25 % in 30 ML Injection | PSN | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1012396 | BUPivacaine HCl 0.25 % Injectable Solution | PSN | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1672917 | BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 10 ML Injection | PSN | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1672919 | BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 30 ML Injection | PSN | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1012384 | BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable Solution | PSN | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1724880 | BUPivacaine HCl 0.5 % in 10 ML Injection | PSN | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1724884 | BUPivacaine HCl 0.5 % in 30 ML Injection | PSN | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1012404 | BUPivacaine HCl 0.5 % Injectable Solution | PSN | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1724787 | BUPivacaine HCl 0.75 % in 10 ML Injection | PSN | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1724786 | BUPivacaine HCl 0.75 % in 30 ML Injection | PSN | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1867594 | 10 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection | SCD | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1725078 | 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1672917 | 10 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection | SCD | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1724880 | 10 ML bupivacaine hydrochloride 5 MG/ML Injection | SCD | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1724787 | 10 ML bupivacaine hydrochloride 7.5 MG/ML Injection | SCD | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1867596 | 30 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection | SCD | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1725082 | 30 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1672919 | 30 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection | SCD | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1724884 | 30 ML bupivacaine hydrochloride 5 MG/ML Injection | SCD | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1724786 | 30 ML bupivacaine hydrochloride 7.5 MG/ML Injection | SCD | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1012377 | bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution | SCD | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1012396 | bupivacaine hydrochloride 2.5 MG/ML Injectable Solution | SCD | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1012384 | bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution | SCD | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1012404 | bupivacaine hydrochloride 5 MG/ML Injectable Solution | SCD | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1867594 | bupivacaine HCl 0.25 % / epinephrine (as bitartrate) 1:200,000 per 10 mL Injection | SY | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1867596 | bupivacaine HCl 0.25 % / epinephrine 1:200,000 per 30 ML Injection | SY | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1725078 | bupivacaine HCl 0.25 % in 10 ML Injection | SY | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1725082 | bupivacaine HCl 0.25 % per 30 ML Injection | SY | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1672917 | bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 10 ML Injection | SY | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1672919 | bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 30 ML Injection | SY | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1724880 | bupivacaine HCl 0.5 % in 10 ML Injection | SY | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1724884 | bupivacaine HCl 0.5 % in 30 ML Injection | SY | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1724787 | bupivacaine HCl 0.75 % in 10 ML Injection | SY | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1724786 | bupivacaine HCl 0.75 % in 30 ML Injection | SY | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1724786 | bupivacaine HCl 225 MG per 30 ML Injection | SY | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1724787 | bupivacaine HCl 75 MG per 10 ML Injection | SY | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1012377 | bupivacaine hydrochloride 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable Solution | SY | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1012396 | bupivacaine hydrochloride 0.25 % Injectable Solution | SY | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1012384 | bupivacaine hydrochloride 0.5 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable Solution | SY | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1012404 | bupivacaine hydrochloride 0.5 % Injectable Solution | SY | 02a845c3-4521-4926-e397-25ab536e7cf6 | 39 |
| 1725078 | BUPivacaine HCl 0.25 % in 10 ML Injection | PSN | bb44c7e1-d911-4788-908f-09b7b271969b | 21 |
| 1725082 | BUPivacaine HCl 0.25 % in 30 ML Injection | PSN | bb44c7e1-d911-4788-908f-09b7b271969b | 21 |
| 1725078 | 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | bb44c7e1-d911-4788-908f-09b7b271969b | 21 |
| 1725082 | 30 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | bb44c7e1-d911-4788-908f-09b7b271969b | 21 |
| 1725078 | bupivacaine HCl 0.25 % in 10 ML Injection | SY | bb44c7e1-d911-4788-908f-09b7b271969b | 21 |
| 1725082 | bupivacaine HCl 0.25 % per 30 ML Injection | SY | bb44c7e1-d911-4788-908f-09b7b271969b | 21 |
| 1725082 | BUPivacaine HCl 0.25 % in 30 ML Injection | PSN | 8f8f4ece-de78-4c13-8d9f-c3bb7053019d | 17 |
| 1725082 | 30 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | 8f8f4ece-de78-4c13-8d9f-c3bb7053019d | 17 |
| 1725082 | bupivacaine HCl 0.25 % per 30 ML Injection | SY | 8f8f4ece-de78-4c13-8d9f-c3bb7053019d | 17 |
| 1725078 | BUPivacaine HCl 0.25 % in 10 ML Injection | PSN | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1725082 | BUPivacaine HCl 0.25 % in 30 ML Injection | PSN | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1737568 | lidocaine HCl 1 % in 2 ML Injection | PSN | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797730 | povidone-iodine 10 % Medicated Pad | PSN | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1725078 | 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1737568 | 2 ML lidocaine hydrochloride 10 MG/ML Injection | SCD | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1725082 | 30 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797730 | povidone-iodine 100 MG/ML Medicated Pad | SCD | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1725078 | bupivacaine HCl 0.25 % in 10 ML Injection | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1725082 | bupivacaine HCl 0.25 % per 30 ML Injection | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1737568 | lidocaine HCl 1 % per 2 ML Injection | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1737568 | lidocaine HCl 20 MG per 2 ML Injection | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797730 | povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797730 | povidone-iodine 10 % Medicated Pad | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797730 | povidone-iodine 10 % Medicated Swabstick | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 578803 | betamethasone sodium phosphate / betamethasone acetate 6 MG/ML Injectable Suspension | PSN | 9a6a3871-4e02-47f9-a20e-a256b3f3c498 | 12 |
| 1725078 | BUPivacaine HCl 0.25 % in 10 ML Injection | PSN | 9a6a3871-4e02-47f9-a20e-a256b3f3c498 | 12 |
| 1725078 | BUPivacaine HCl 0.25 % in 10 ML Injection | PSN | cdd72141-10b6-48c6-85be-5b1294c8539c | 12 |
| 1725082 | BUPivacaine HCl 0.25 % in 30 ML Injection | PSN | cdd72141-10b6-48c6-85be-5b1294c8539c | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0409-1159-01 | 00409115901 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1159-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) | 2005-05-06 | 0000-00-00 | No | No | Current | |
| 0409-1159-02 | 00409115902 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1159-02) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1159-19) | 2005-08-15 | 0000-00-00 | No | No | Current | |
| 0409-1159-09 | 00409115909 | 30 mL in 1 VIAL, SINGLE-DOSE | 30 ml | Historical | ||||
| 0409-1159-10 | 00409115910 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1159-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1159-09) | 2015-08-11 | 0000-00-00 | No | No | Current | |
| 0409-1159-18 | 00409115918 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | Historical | ||||
| 0409-1159-19 | 00409115919 | 30 mL in 1 VIAL, SINGLE-DOSE | 30 ml | Historical |