Application 212819

Type: NDA
Sponsor: MSD MERCK CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RECARBRIO	CILASTATIN SODIUM; IMIPENEM; RELEBACTAM	POWDER;INTRAVENOUS	EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212819-001	RECARBRIO	EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2019-07-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212819-001	RECARBRIO	EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2019-07-16	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
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#

Exclusivity history page 1 of 2 · 77 observed states.

Captured, Edition, Application-product table
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…`

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-3856	RECARBRIO	imipenem anhydrous, cilastatin, and relebactam anhydrous	Merck Sharp & Dohme Corp.	NDA	Current
0006-3856	RECARBRIO	imipenem anhydrous, cilastatin, and relebactam anhydrous	Merck Sharp & Dohme Corp.	NDA	Current
0006-3856	RECARBRIO	imipenem anhydrous, cilastatin, and relebactam anhydrous	Merck Sharp & Dohme Corp.	NDA	Current
0006-3856	RECARBRIO	imipenem anhydrous, cilastatin, and relebactam anhydrous	Merck Sharp & Dohme LLC	NDA	Current
0006-3856	RECARBRIO	imipenem anhydrous, cilastatin, and relebactam anhydrous	Merck Sharp & Dohme Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84441	SUPPL	2025-12-18
84375	SUPPL	2025-12-10
63428	SUPPL	2020-06-08
63426	SUPPL	2020-06-05
59529	ORIG	2019-07-31
59371	ORIG	2019-07-31
59370	ORIG	2019-07-18