RECARBRIO

Product NDC: 0006-3856
11-digit product format: 000063856
Labeler code: 0006
Product ID: 0006-3856_11f74255-d000-4759-a561-136a5f13f667
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
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, RS	2019-07-16

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
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#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	N212819-001	RECARBRIO	EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2019-07-16	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212819-001	8487093	2033-03-21	U-2840	Drug substance, Drug product	2019-08-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212819-001	8487093	2033-03-21	U-2586	Drug substance, Drug product	2019-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212819-001	8487093	2033-03-21	U-2587	Drug substance, Drug product	2019-08-13	`301d65b070ca…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
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…`
2022-04-08 23:34 UTC	2022-04	N212819-001	NCE	2024-07-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212819-001	GAIN	2029-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212819-001	NCE	2024-07-16	`4b0b4de00fa7…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IMIPENEM ANHYDROUS	500 mg/100mL
CILASTATIN	500 mg/100mL
RELEBACTAM ANHYDROUS	250 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q20IM7HE75	Internal UNII lookup
141A6AMN38	Internal UNII lookup
1OQF7TT3PF	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2184142	Internal RxNorm lookup
2184147	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
be32f468-738b-40df-a425-591e12f65159	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
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 table
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 table
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

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RECARBRIO	IMIPENEM ANHYDROUS, CILASTATIN, AND RELEBACTAM ANHYDROUS	Merck Sharp & Dohme LLC	be32f468-738b-40df-a425-591e12f65159	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212819 application number: NDA212819 ndc (product): 0006-3856

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q20IM7HE75	IMIPENEM ANHYDROUS	64221-86-9	IMIPENEM ANHYDROUS
141A6AMN38	CILASTATIN	82009-34-5	CILASTATIN
1OQF7TT3PF	RELEBACTAM ANHYDROUS	1174018-99-5	RELEBACTAM ANHYDROUS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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 table
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