Bupivacaine Hydrochloride
- Product NDC
- 0409-1162
- 11-digit product format
- 004091162
- Labeler code
- 0409
- Product ID
- 0409-1162_6e442bfd-d3da-4913-8585-ce3485644364
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPIVACAINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INTRACAUDAL; PERINEURAL
- Labeler
- Hospira, Inc.
- Application
- ANDA070584
- Marketing category
- ANDA
- Marketing start
- 2005-11-22
- 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
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0409-1162 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 0409-1162 | 0409-1162-10 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0409-1162-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0409-1162-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0409-1162-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0409-1162-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0409-1162-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0409-1162-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0409-1162-10 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0409-1162-10 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0409-1162-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0409-1162-10 | ad56d346431e… | cc804d4bbf1e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A070584-001 | BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A070584-001 | 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 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A070584-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 1986-02-17 | 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 | A070584-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A070584-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070584-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A070584-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070584-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070584-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070584-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070584-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070584-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070584-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A070584-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070584-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070584-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070584-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A070584-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A070584-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A070584-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A070584-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A070584-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A070584-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A070584-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A070584-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A070584-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A070584-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A070584-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A070584-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A070584-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A070584-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A070584-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A070584-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A070584-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A070584-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A070584-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A070584-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A070584-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A070584-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A070584-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A070584-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A070584-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A070584-001 | 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 | 5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 30Q7KI53AK | Internal UNII lookup |
| 7TQO7W3VT8 | 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 |
|---|---|---|---|---|---|---|
| 0409-1162-01 | Bupivacaine Hydrochloride | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 39 | |
| 0409-1162-02 | Bupivacaine Hydrochloride | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 39 | |
| 0409-1162-18 | Bupivacaine Hydrochloride | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | 39 | |
| 0409-1162-19 | Bupivacaine Hydrochloride | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | 39 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0409-1162-01 | ML - Milliliter | 0409-1162 | 783a1da9-21e7-4b4d-bb53-fd96fba6e476 | 1 | 2012-07-24 |
| 0409-1162-02 | ML - Milliliter | 0409-1162 | 8c33a692-de53-43c2-81ae-a54f87598416 | 1 | 2012-07-24 |
| 0409-1162-09 | ML - Milliliter | 0409-1162 | d5bee654-dc47-4c8e-9ac1-b2afe694d7b4 | 1 | 2017-03-06 |
| 0409-1162-10 | ML - Milliliter | 0409-1162 | ceee243a-29bd-4bba-bea2-8831b1f255e8 | 1 | 2017-03-06 |
| 0409-1162-18 | ML - Milliliter | 0409-1162 | b43f8f3f-4e30-4160-b4ee-b15826ddf1ec | 1 | 2017-07-07 |
| 0409-1162-19 | ML - Milliliter | 0409-1162 | c1957b0d-3cdd-46da-90cf-96ddd13eee17 | 1 | 2017-03-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0409-1162 | 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 |
| 0409-1162 | BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 19 | Current NDC, Legacy NDC | 20241105_bb44c7e1-d911-4788-908f-09b7b271969b.zip |
| 0409-1162 | BUPIVILOG KIT (MARCAINE, KENALOG, POVIDONE IODINE) KIT [ASCLEMED USA, INC.] | 13 | Current NDC, Legacy NDC | 20241008_9d485952-e8f5-4ec9-bab2-6ee4217e807a.zip |
| 0409-1162 | MARLIDO KIT (MARCAINE, LIDOCAINE, POVIDONE IODINE) KIT [ASCLEMED USA, INC.] | 13 | Current NDC, Legacy NDC | 20250112_e942a88a-7cb1-4c99-b70f-4c48994bb84e.zip |
| 0409-1162 | MLK F1 KIT (MARCAINE, LIDOCAINE, KENALOG, POVIDONE IODINE) KIT [ASCLEMED USA, INC.] | 13 | Current NDC, Legacy NDC | 20241008_0cd42a2f-d202-447d-998e-8877ac3c0d38.zip |
| 0409-1162 | MLK KIT F2 (MARCAINE, LIDOCAINE, KENALOG, POVIDONE IODINE) KIT [ASCLEMED USA, INC.] | 13 | Current NDC, Legacy NDC | 20241008_08990ac8-3215-4b84-b2be-23298edbddf4.zip |
| 0409-1162 | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [ASCLEMED USA, INC.] | 13 | Current NDC, Legacy NDC | 20241101_dec92845-e713-42a3-83a7-3a48920b7eed.zip |
| 0409-1162 | MLK F3 KIT (MARCAINE, LIDOCAINE, KENALOG, POVIDONE IODINE) KIT [ASCLEMED USA, INC.] | 11 | Current NDC, Legacy NDC | 20241008_481aeef5-01cb-4567-a67f-896e6929b2ed.zip |
| 0409-1162 | MLK F4 KIT (TRIAMCINOLONE ACETONIDE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] | 11 | Current NDC, Legacy NDC | 20241008_829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c.zip |
| 0409-1162 | BUPIVILOG KIT (MARCAINE, KENALOG, POVIDONE IODINE) KIT [ADVANCED RX OF TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC | 20250102_01cb7b47-2c40-707d-e063-6294a90a5d97.zip |
| 0409-1162 | MLK KIT F2 (MARCAINE, LIDOCAINE, KENALOG, POVIDONE IODINE) KIT [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC | 20250410_325d93c6-d97b-a45c-e063-6294a90a974f.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 | Hospira, Inc. | 02a845c3-4521-4926-e397-25ab536e7cf6 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | 070584 ANDA070584 0409-1162 |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | Sportpharm LLC | 0e6a55f0-5107-4ea9-9ee1-5c6c09bbe4a6 | 2026-02-03 | Boxed warning, Warnings, Adverse reactions | 070584 ANDA070584 |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | ProPharma Distribution | 42c973e2-307b-924c-e063-6394a90a737a | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 070584 ANDA070584 |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | Asclemed USA, Inc. | 8759cac8-d977-4c2a-814c-5b59f2f0c910 | 2023-08-09 | Boxed warning, Warnings, Adverse reactions | 070584 ANDA070584 |
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 |
| 1724880 | BUPivacaine HCl 0.5 % in 10 ML Injection | PSN | 08990ac8-3215-4b84-b2be-23298edbddf4 | 14 |
| 1724880 | BUPivacaine HCl 0.5 % in 10 ML Injection | PSN | 0cd42a2f-d202-447d-998e-8877ac3c0d38 | 14 |
| 1724880 | BUPivacaine HCl 0.5 % in 10 ML Injection | PSN | 9d485952-e8f5-4ec9-bab2-6ee4217e807a | 14 |
| 1737757 | lidocaine HCl 2 % in 2 ML Injection | PSN | 0cd42a2f-d202-447d-998e-8877ac3c0d38 | 14 |
| 1737761 | lidocaine HCl 2 % in 5 ML Injection | PSN | 08990ac8-3215-4b84-b2be-23298edbddf4 | 14 |
| 797730 | povidone-iodine 10 % Medicated Pad | PSN | 0cd42a2f-d202-447d-998e-8877ac3c0d38 | 14 |
| 797730 | povidone-iodine 10 % Medicated Pad | PSN | 08990ac8-3215-4b84-b2be-23298edbddf4 | 14 |
| 797730 | povidone-iodine 10 % Medicated Pad | PSN | 9d485952-e8f5-4ec9-bab2-6ee4217e807a | 14 |
| 1792144 | triamcinolone acetonide 40 MG in 1 ML Injection | PSN | 0cd42a2f-d202-447d-998e-8877ac3c0d38 | 14 |
| 1792144 | triamcinolone acetonide 40 MG in 1 ML Injection | PSN | 9d485952-e8f5-4ec9-bab2-6ee4217e807a | 14 |
| 1792144 | triamcinolone acetonide 40 MG in 1 ML Injection | PSN | 08990ac8-3215-4b84-b2be-23298edbddf4 | 14 |
| 1792144 | 1 ML triamcinolone acetonide 40 MG/ML Injection | SCD | 08990ac8-3215-4b84-b2be-23298edbddf4 | 14 |
| 1792144 | 1 ML triamcinolone acetonide 40 MG/ML Injection | SCD | 0cd42a2f-d202-447d-998e-8877ac3c0d38 | 14 |
| 1792144 | 1 ML triamcinolone acetonide 40 MG/ML Injection | SCD | 9d485952-e8f5-4ec9-bab2-6ee4217e807a | 14 |
| 1724880 | 10 ML bupivacaine hydrochloride 5 MG/ML Injection | SCD | 08990ac8-3215-4b84-b2be-23298edbddf4 | 14 |
| 1724880 | 10 ML bupivacaine hydrochloride 5 MG/ML Injection | SCD | 0cd42a2f-d202-447d-998e-8877ac3c0d38 | 14 |
| 1724880 | 10 ML bupivacaine hydrochloride 5 MG/ML Injection | SCD | 9d485952-e8f5-4ec9-bab2-6ee4217e807a | 14 |
| 1737757 | 2 ML lidocaine hydrochloride 20 MG/ML Injection | SCD | 0cd42a2f-d202-447d-998e-8877ac3c0d38 | 14 |
| 1737761 | 5 ML lidocaine hydrochloride 20 MG/ML Injection | SCD | 08990ac8-3215-4b84-b2be-23298edbddf4 | 14 |
| 797730 | povidone-iodine 100 MG/ML Medicated Pad | SCD | 9d485952-e8f5-4ec9-bab2-6ee4217e807a | 14 |
| 797730 | povidone-iodine 100 MG/ML Medicated Pad | SCD | 0cd42a2f-d202-447d-998e-8877ac3c0d38 | 14 |
| 797730 | povidone-iodine 100 MG/ML Medicated Pad | SCD | 08990ac8-3215-4b84-b2be-23298edbddf4 | 14 |
| 1724880 | bupivacaine HCl 0.5 % in 10 ML Injection | SY | 08990ac8-3215-4b84-b2be-23298edbddf4 | 14 |
| 1724880 | bupivacaine HCl 0.5 % in 10 ML Injection | SY | 9d485952-e8f5-4ec9-bab2-6ee4217e807a | 14 |
| 1724880 | bupivacaine HCl 0.5 % in 10 ML Injection | SY | 0cd42a2f-d202-447d-998e-8877ac3c0d38 | 14 |
| 1737761 | lidocaine HCl 100 MG per 5 ML Injection | SY | 08990ac8-3215-4b84-b2be-23298edbddf4 | 14 |
| 1737757 | lidocaine HCl 2 % per 2 ML Injection | SY | 0cd42a2f-d202-447d-998e-8877ac3c0d38 | 14 |
| 1737761 | lidocaine HCl 2 % per 5 ML Injection | SY | 08990ac8-3215-4b84-b2be-23298edbddf4 | 14 |
| 1737757 | lidocaine HCl 40 MG per 2 ML Injection | SY | 0cd42a2f-d202-447d-998e-8877ac3c0d38 | 14 |
| 797730 | povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad | SY | 0cd42a2f-d202-447d-998e-8877ac3c0d38 | 14 |
| 797730 | povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad | SY | 08990ac8-3215-4b84-b2be-23298edbddf4 | 14 |
| 797730 | povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad | SY | 9d485952-e8f5-4ec9-bab2-6ee4217e807a | 14 |
| 797730 | povidone-iodine 10 % Medicated Pad | SY | 9d485952-e8f5-4ec9-bab2-6ee4217e807a | 14 |
| 797730 | povidone-iodine 10 % Medicated Pad | SY | 0cd42a2f-d202-447d-998e-8877ac3c0d38 | 14 |
| 797730 | povidone-iodine 10 % Medicated Pad | SY | 08990ac8-3215-4b84-b2be-23298edbddf4 | 14 |
| 797730 | povidone-iodine 10 % Medicated Swabstick | SY | 9d485952-e8f5-4ec9-bab2-6ee4217e807a | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0409-1162-01 | 00409116201 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1162-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-1162-18) | 2006-03-08 | 0000-00-00 | No | No | Current | |
| 0409-1162-02 | 00409116202 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1162-02) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1162-19) | 2005-11-22 | 0000-00-00 | No | No | Current | |
| 0409-1162-10 | 00409116210 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1162-10) > 30 mL in 1 VIAL, SINGLE-DOSE (0409-1162-09) | 2017-02-07 | 0000-00-00 | No | No | Current | |
| 0409-1162-18 | 00409116218 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | Historical | ||||
| 0409-1162-19 | 00409116219 | 30 mL in 1 VIAL, SINGLE-DOSE | 30 ml | Historical |