bupivacaine hydrochloride
- Product NDC
- 71288-721
- Requested package NDC
- 71288-721-11
- 11-digit product format
- 712880721
- Labeler code
- 71288
- Product ID
- 71288-721_05aa974a-bfed-44d5-9dba-0427a76ff70b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupivacaine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
- Labeler
- Meitheal Pharmaceuticals Inc
- Application
- ANDA216040
- Marketing category
- ANDA
- Marketing start
- 2023-12-27
- Marketing end
- 2026-07-21
- Substance
- BUPIVACAINE HYDROCHLORIDE
- Active strength
- 2.5 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- 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 package | package | 71288-721 | 71288-721-11 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216040-001 | BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | 2023-12-27 | ||
| A216040-002 | BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2023-12-27 | ||
| A216040-003 | BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | 2023-12-27 |
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 | A216040-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | 2023-12-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216040-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2023-12-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216040-003 | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | 2023-12-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216040-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2023-12-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216040-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2023-12-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216040-003 | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | AP | 2023-12-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216040-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2023-12-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216040-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2023-12-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216040-003 | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | AP | 2023-12-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216040-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2023-12-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216040-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2023-12-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216040-003 | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | AP | 2023-12-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216040-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2023-12-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216040-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2023-12-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216040-003 | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | AP | 2023-12-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216040-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2023-12-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216040-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2023-12-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216040-003 | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | AP | 2023-12-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216040-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2023-12-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216040-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2023-12-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216040-003 | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | AP | 2023-12-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216040-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2023-12-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216040-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2023-12-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216040-003 | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | AP | 2023-12-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216040-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2023-12-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216040-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2023-12-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216040-003 | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | AP | 2023-12-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216040-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2023-12-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216040-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2023-12-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216040-003 | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | AP | 2023-12-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216040-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2023-12-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216040-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2023-12-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216040-003 | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | AP | 2023-12-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216040-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2023-12-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216040-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2023-12-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216040-003 | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | AP | 2023-12-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216040-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2023-12-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216040-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2023-12-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216040-003 | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | AP | 2023-12-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216040-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2023-12-27 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A216040-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216040-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216040-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216040-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216040-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216040-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216040-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216040-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216040-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216040-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216040-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216040-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216040-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216040-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216040-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216040-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216040-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216040-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216040-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216040-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216040-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216040-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216040-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216040-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216040-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216040-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216040-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A216040-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216040-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216040-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216040-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216040-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216040-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216040-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216040-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216040-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216040-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216040-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216040-003 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A216040-001 | AP | 1 | 8072bd15b7f6… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cbf85893-59ef-423f-87d4-a573c000a8b9 | Product name | 8 | 20250731 |
| 5dad6767-dcd1-b0da-8727-7f3f7bc3a435 | Product name | 2 | 20250303 |
| e3a99641-4540-4894-9108-00cab3c57b7e | Product name | 1 | 20211207 |
| 5da98533-f072-406b-9e1b-6ac19eca9926 | Product name | 1 | 20210622 |
| 306b993e-3140-4823-ad5e-88b708f9d2ac | Product name | 1 | 20210510 |
| a831e694-3663-4a83-82be-6c309429f750 | Product name | 2 | 20200608 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71288-721-11 | bupivacaine hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 2 | |
| 71288-721-11 | bupivacaine hydrochloride | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71288-721-11 | ML - Milliliter | 71288-721 | 5828a4ee-d36e-4d78-94e5-ed1e99d7fdcd | 1 | 2024-03-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1725078 | BUPivacaine HCl 0.25 % in 10 ML Injection | PSN | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1725082 | BUPivacaine HCl 0.25 % in 30 ML Injection | PSN | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1724880 | BUPivacaine HCl 0.5 % in 10 ML Injection | PSN | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1724884 | BUPivacaine HCl 0.5 % in 30 ML Injection | PSN | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1724787 | BUPivacaine HCl 0.75 % in 10 ML Injection | PSN | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1724786 | BUPivacaine HCl 0.75 % in 30 ML Injection | PSN | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1725078 | 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1724880 | 10 ML bupivacaine hydrochloride 5 MG/ML Injection | SCD | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1724787 | 10 ML bupivacaine hydrochloride 7.5 MG/ML Injection | SCD | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1725082 | 30 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1724884 | 30 ML bupivacaine hydrochloride 5 MG/ML Injection | SCD | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1724786 | 30 ML bupivacaine hydrochloride 7.5 MG/ML Injection | SCD | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1725078 | bupivacaine HCl 0.25 % in 10 ML Injection | SY | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1725082 | bupivacaine HCl 0.25 % per 30 ML Injection | SY | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1724880 | bupivacaine HCl 0.5 % in 10 ML Injection | SY | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1724884 | bupivacaine HCl 0.5 % in 30 ML Injection | SY | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1724787 | bupivacaine HCl 0.75 % in 10 ML Injection | SY | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1724786 | bupivacaine HCl 0.75 % in 30 ML Injection | SY | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1724786 | bupivacaine HCl 225 MG per 30 ML Injection | SY | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
| 1724787 | bupivacaine HCl 75 MG per 10 ML Injection | SY | daec9ee4-b666-485e-a153-4b5e5acc48a1 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71288-721-11 | 71288072111 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-721-11) / 10 mL in 1 VIAL, SINGLE-DOSE | 2023-12-27 | 2026-06-07 | No | No | Historical |