RECARBRIO
- Product NDC
- 0006-3856
- 11-digit product format
- 000063856
- Labeler code
- 0006
- Product ID
- 0006-3856_128d22eb-7136-4c07-8827-21a27fb99ede
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- imipenem anhydrous, cilastatin, and relebactam anhydrous
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Merck Sharp & Dohme LLC
- Application
- NDA212819
- Marketing category
- NDA
- Marketing start
- 2020-01-06
- Substance
- IMIPENEM ANHYDROUS; CILASTATIN; RELEBACTAM ANHYDROUS
- Active strength
- 500; 500; 250 mg/100mL; mg/100mL; mg/100mL
- Pharmacologic classes
- Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
- 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 |
|---|---|---|---|---|---|---|---|
| N212819-001 | RECARBRIO | CILASTATIN SODIUM; IMIPENEM; RELEBACTAM | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD | 2019-07-16 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N212819-001 | 8487093 | 2033-03-21 | U-2586 | Drug substance, Drug product | 2019-08-13 |
| N212819-001 | 8487093 | 2033-03-21 | U-2587 | Drug substance, Drug product | 2019-08-13 |
| N212819-001 | 8487093 | 2033-03-21 | U-2840 | Drug substance, Drug product | 2019-08-13 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N212819-001 | NCE | 2024-07-16 |
| N212819-001 | NPP | 2028-12-09 |
| N212819-001 | GAIN | 2029-07-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD | 2019-07-16 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | b00525d2431f… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N212819-001 | RECARBRIO | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2019-07-16 | f41ea6bd6efb… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N212819-001 | 8487093 | 2033-03-21 | U-2587 | Drug substance, Drug product | 2019-08-13 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212819-001 | 8487093 | 2033-03-21 | U-2840 | Drug substance, Drug product | 2019-08-13 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212819-001 | 8487093 | 2033-03-21 | U-2586 | Drug substance, Drug product | 2019-08-13 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N212819-001 | 8487093 | 2033-03-21 | U-2587 | Drug substance, Drug product | 2019-08-13 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212819-001 | 8487093 | 2033-03-21 | U-2840 | Drug substance, Drug product | 2019-08-13 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212819-001 | 8487093 | 2033-03-21 | U-2586 | Drug substance, Drug product | 2019-08-13 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N212819-001 | 8487093 | 2033-03-21 | U-2587 | Drug substance, Drug product | 2019-08-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212819-001 | 8487093 | 2033-03-21 | U-2840 | Drug substance, Drug product | 2019-08-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212819-001 | 8487093 | 2033-03-21 | U-2586 | Drug substance, Drug product | 2019-08-13 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N212819-001 | 8487093 | 2033-03-21 | U-2587 | Drug substance, Drug product | 2019-08-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N212819-001 | 8487093 | 2033-03-21 | U-2840 | Drug substance, Drug product | 2019-08-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N212819-001 | 8487093 | 2033-03-21 | U-2586 | Drug substance, Drug product | 2019-08-13 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212819-001 | 8487093 | 2033-03-21 | U-2587 | Drug substance, Drug product | 2019-08-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212819-001 | 8487093 | 2033-03-21 | U-2840 | Drug substance, Drug product | 2019-08-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212819-001 | 8487093 | 2033-03-21 | U-2586 | Drug substance, Drug product | 2019-08-13 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N212819-001 | 8487093 | 2033-03-21 | U-2587 | Drug substance, Drug product | 2019-08-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N212819-001 | 8487093 | 2033-03-21 | U-2840 | Drug substance, Drug product | 2019-08-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N212819-001 | 8487093 | 2033-03-21 | U-2586 | Drug substance, Drug product | 2019-08-13 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212819-001 | 8487093 | 2033-03-21 | U-2587 | Drug substance, Drug product | 2019-08-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212819-001 | 8487093 | 2033-03-21 | U-2840 | Drug substance, Drug product | 2019-08-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212819-001 | 8487093 | 2033-03-21 | U-2586 | Drug substance, Drug product | 2019-08-13 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212819-001 | 8487093 | 2033-03-21 | U-2587 | Drug substance, Drug product | 2019-08-13 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212819-001 | 8487093 | 2033-03-21 | U-2840 | Drug substance, Drug product | 2019-08-13 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212819-001 | 8487093 | 2033-03-21 | U-2586 | Drug substance, Drug product | 2019-08-13 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212819-001 | 8487093 | 2033-03-21 | U-2587 | Drug substance, Drug product | 2019-08-13 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212819-001 | 8487093 | 2033-03-21 | U-2840 | Drug substance, Drug product | 2019-08-13 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212819-001 | 8487093 | 2033-03-21 | U-2586 | Drug substance, Drug product | 2019-08-13 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212819-001 | 8487093 | 2033-03-21 | U-2587 | Drug substance, Drug product | 2019-08-13 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212819-001 | 8487093 | 2033-03-21 | U-2840 | Drug substance, Drug product | 2019-08-13 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212819-001 | 8487093 | 2033-03-21 | U-2586 | Drug substance, Drug product | 2019-08-13 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212819-001 | 8487093 | 2033-03-21 | U-2587 | Drug substance, Drug product | 2019-08-13 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212819-001 | 8487093 | 2033-03-21 | U-2840 | Drug substance, Drug product | 2019-08-13 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212819-001 | 8487093 | 2033-03-21 | U-2586 | Drug substance, Drug product | 2019-08-13 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212819-001 | 8487093 | 2033-03-21 | U-2587 | Drug substance, Drug product | 2019-08-13 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212819-001 | 8487093 | 2033-03-21 | U-2840 | Drug substance, Drug product | 2019-08-13 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212819-001 | 8487093 | 2033-03-21 | U-2586 | Drug substance, Drug product | 2019-08-13 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N212819-001 | 8487093 | 2033-03-21 | U-2587 | Drug substance, Drug product | 2019-08-13 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N212819-001 | 8487093 | 2033-03-21 | U-2840 | Drug substance, Drug product | 2019-08-13 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N212819-001 | 8487093 | 2033-03-21 | U-2586 | Drug substance, Drug product | 2019-08-13 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212819-001 | 8487093 | 2033-03-21 | U-2587 | Drug substance, Drug product | 2019-08-13 | 79d66fd596c7… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N212819-001 | NCE | 2024-07-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212819-001 | NPP | 2028-12-09 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212819-001 | GAIN | 2029-07-16 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N212819-001 | NCE | 2024-07-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212819-001 | NPP | 2028-12-09 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212819-001 | GAIN | 2029-07-16 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N212819-001 | NCE | 2024-07-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212819-001 | NPP | 2028-12-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212819-001 | GAIN | 2029-07-16 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N212819-001 | NCE | 2024-07-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N212819-001 | NPP | 2028-12-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N212819-001 | GAIN | 2029-07-16 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212819-001 | NCE | 2024-07-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212819-001 | GAIN | 2029-07-16 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N212819-001 | NCE | 2024-07-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N212819-001 | GAIN | 2029-07-16 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212819-001 | NCE | 2024-07-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212819-001 | GAIN | 2029-07-16 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212819-001 | NCE | 2024-07-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212819-001 | GAIN | 2029-07-16 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212819-001 | NCE | 2024-07-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212819-001 | GAIN | 2029-07-16 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212819-001 | NCE | 2024-07-16 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212819-001 | GAIN | 2029-07-16 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212819-001 | NCE | 2024-07-16 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212819-001 | GAIN | 2029-07-16 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212819-001 | NCE | 2024-07-16 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212819-001 | GAIN | 2029-07-16 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N212819-001 | NCE | 2024-07-16 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N212819-001 | GAIN | 2029-07-16 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212819-001 | NCE | 2024-07-16 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212819-001 | GAIN | 2029-07-16 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212819-001 | NCE | 2024-07-16 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212819-001 | GAIN | 2029-07-16 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N212819-001 | NCE | 2024-07-16 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N212819-001 | GAIN | 2029-07-16 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N212819-001 | NCE | 2024-07-16 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N212819-001 | GAIN | 2029-07-16 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N212819-001 | NCE | 2024-07-16 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N212819-001 | GAIN | 2029-07-16 | 5c6f7cd8ea54… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RECARBRIO
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| IMIPENEM ANHYDROUS | 500 mg/100mL |
| CILASTATIN | 500 mg/100mL |
| RELEBACTAM ANHYDROUS | 250 mg/100mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| bd5bade3-1b69-46d8-87bd-7d2fbe32b767 | Product name | 1 | 20200603 |
| bc64ce14-a963-4b05-9b71-737977847052 | Product name | 1 | 20191008 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0006-3856-01 | RECARBRIO | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, FOR SOLUTION | 20 | 11 | |
| 0006-3856-02 | RECARBRIO | 25 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 25 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0006-3856-01 | EA - Each | 0006-3856 | 38e435cb-5843-478d-a005-4c53433f6ffe | 1 | 2020-02-13 |
| 0006-3856-02 | EA - Each | 0006-3856 | e65e4522-e668-441c-99b1-8048e6d43096 | 1 | 2020-02-13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0006-3856 | RECARBRIO (IMIPENEM ANHYDROUS, CILASTATIN, AND RELEBACTAM ANHYDROUS) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241107_be32f468-738b-40df-a425-591e12f65159.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2184142 | cilastatin 500 MG / imipenem 500 MG / relebactam 250 MG Injection | PSN | be32f468-738b-40df-a425-591e12f65159 | 11 |
| 2184147 | Recarbrio 500 MG / 500 MG / 250 MG Injection | PSN | be32f468-738b-40df-a425-591e12f65159 | 11 |
| 2184147 | cilastatin 500 MG / imipenem 500 MG / relebactam 250 MG Injection [Recarbrio] | SBD | be32f468-738b-40df-a425-591e12f65159 | 11 |
| 2184142 | cilastatin 500 MG / imipenem 500 MG / relebactam 250 MG Injection | SCD | be32f468-738b-40df-a425-591e12f65159 | 11 |
| 2184147 | Recarbrio 1.25 GM Injection | SY | be32f468-738b-40df-a425-591e12f65159 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0006-3856-01 | 00006385601 | 20 mL in 1 VIAL, SINGLE-DOSE | 20 ml | Historical | ||||
| 0006-3856-02 | 00006385602 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0006-3856-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0006-3856-01) | 2020-01-06 | 0000-00-00 | No | No | Current |