BUPIVACAINE HYDROCHLORIDE injection, solution
- Product NDC
- 51662-1638
- 11-digit product format
- 516621638
- Labeler code
- 51662
- Product ID
- 51662-1638_0f952dd8-92a8-2eb0-e063-6394a90a8c35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPIVACAINE HYDROCHLORIDE injection, solution
- Dosage form
- INJECTION, SOLUTION
- Route
- PERINEURAL
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA207183
- Marketing category
- ANDA
- Marketing start
- 2016-05-13
- Substance
- BUPIVACAINE HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207183-001 | BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | |
| A207183-002 | BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207183-001 | AP |
| A207183-002 | 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 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207183-001 | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | 2016-05-13 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207183-002 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | 2016-05-13 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207183-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207183-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207183-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207183-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207183-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207183-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207183-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207183-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207183-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207183-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207183-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207183-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207183-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207183-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207183-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207183-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207183-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207183-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207183-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207183-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207183-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207183-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207183-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207183-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207183-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207183-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207183-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207183-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207183-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A207183-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207183-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207183-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A207183-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A207183-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A207183-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A207183-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A207183-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207183-002 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A207183-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A207183-002 | AP | 1 | bb7c543d1eb4… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BUPIVACAINE HYDROCHLORIDE injection, solution
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUPIVACAINE HYDROCHLORIDE | 5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7TQO7W3VT8 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1012404 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 06c15208-c600-7173-e063-6394a90a2f94 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51662-1638-2 | BUPIVACAINE HYDROCHLORIDE injection, solution | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | 2 | |
| 51662-1638-2 | BUPIVACAINE HYDROCHLORIDE injection, solution | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | 2 | |
| 51662-1638-3 | BUPIVACAINE HYDROCHLORIDE injection, solution | 25 in 1 CASE | INJECTION, SOLUTION | 25 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51662-1638 | BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 2 | Current NDC, 3 package rows | 20240123_06c15208-c600-7173-e063-6394a90a2f94.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 | Eugia US LLC | ffecf450-1f01-4721-8e10-251385852612 | 2025-05-29 | Boxed warning, Warnings, Adverse reactions | 207183 ANDA207183 |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | A-S Medication Solutions | 1091d4d8-5dad-46e1-8f26-7bc0c5dd833f | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | 207183 ANDA207183 |
| BUPIVACAINE HCI | BUPIVACAINE HCI | HF Acquisition Co LLC, DBA HealthFirst | e37e1599-db88-2fcd-e053-2995a90a00e5 | 2024-01-22 | Boxed warning, Warnings, Adverse reactions | 207183 ANDA207183 |
| BUPIVACAINE HYDROCHLORIDE injection, solution | BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION | HF Acquisition Co LLC, DBA HealthFirst | 06c15208-c600-7173-e063-6394a90a2f94 | 2024-01-22 | Boxed warning, Warnings, Adverse reactions | 207183 ANDA207183 51662-1638 |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 694926ac-aff0-aa1f-e053-2991aa0a9588 | 2023-05-22 | Boxed warning, Warnings, Adverse reactions | 207183 ANDA207183 |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | d1642239-4230-b679-e053-2a95a90a3b7c | 2023-05-02 | Boxed warning, Warnings, Adverse reactions | 207183 ANDA207183 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1012404 | BUPivacaine HCl 0.5 % Injectable Solution | PSN | 06c15208-c600-7173-e063-6394a90a2f94 | 2 |
| 1012404 | bupivacaine hydrochloride 5 MG/ML Injectable Solution | SCD | 06c15208-c600-7173-e063-6394a90a2f94 | 2 |
| 1012404 | bupivacaine hydrochloride 0.5 % Injectable Solution | SY | 06c15208-c600-7173-e063-6394a90a2f94 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51662-1638-2 | 51662163802 | 50 mL in 1 VIAL, MULTI-DOSE | 50 ml | Historical | |||
| 51662-1638-3 | 51662163803 | 25 POUCH in 1 CASE (51662-1638-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1638-2) / 50 mL in 1 VIAL, MULTI-DOSE | 25 pouch | 2023-10-02 | No | No | Current |