Meropenem and Sodium Chloride

Product NDC: 0264-3185
11-digit product format: 002643185
Labeler code: 0264
Product ID: 0264-3185_19ddbcf7-2edf-449b-b49c-b96ddb82d6c2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meropenem and Sodium Chloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: B. Braun Medical Inc.
Application: NDA202106
Marketing category: NDA
Marketing start: 2015-04-30
Substance: MEROPENEM
Active strength: 1 g/50mL
Pharmacologic classes: Carbapenems [CS], Penem Antibacterial [EPC]
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	MEROPENEM	500MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-04-30
N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	MEROPENEM	1GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-04-30

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202106-001	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	500MG/VIAL	POWDER / INTRAVENOUS	2015-04-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202106-002	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	1GM/VIAL	POWDER / INTRAVENOUS	2015-04-30	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Meropenem and Sodium Chloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEROPENEM	1 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FV9J3JU8B1	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1722934	Internal RxNorm lookup
1722939	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
3b952a55-6ef7-45c8-be21-16eefe37ec2e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
437602ae-8b0a-4f4e-8f97-eabd2e27845e	Product name	6	20250305
407c0246-8bda-450d-8667-f622a350d05c	Product name	1	20231023
b1a98f8c-7b20-4bc2-b772-289c5d0949a9	Product name	1	20171106
940e5686-419d-4429-a15d-7bf46e26b176	Product name	1	20150929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0264-3185-11	Meropenem and Sodium Chloride	50 mL in 1 CONTAINER	INJECTION, SOLUTION	50		25
0264-3185-11	Meropenem and Sodium Chloride	24 in 1 CASE	INJECTION, SOLUTION	24		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0264-3185-11	EA - Each	0264-3185	2a6238b2-e15b-4812-8256-656f243e2c87	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MEROPENEM	ACTIVE INGREDIENT	FV9J3JU8B1	MEROPENEM AND SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	9
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	MEROPENEM AND SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	9
MEROPENEM ANHYDROUS	ACTIVE MOIETY	YOP6PX0BAO	MEROPENEM AND SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	9
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	MEROPENEM AND SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	MEROPENEM AND SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0264-3185	MEROPENEM AND SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	24	Current NDC, Legacy NDC, 2 package rows	20250104_3b952a55-6ef7-45c8-be21-16eefe37ec2e.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
Meropenem and Sodium Chloride	MEROPENEM AND SODIUM CHLORIDE	B. Braun Medical Inc.	3b952a55-6ef7-45c8-be21-16eefe37ec2e	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202106 application number: NDA202106 ndc (product): 0264-3185

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FV9J3JU8B1	MEROPENEM	119478-56-7	MEROPENEM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1722939	meropenem 1 GM Injection	PSN	3b952a55-6ef7-45c8-be21-16eefe37ec2e	25
1722934	meropenem 500 MG Injection	PSN	3b952a55-6ef7-45c8-be21-16eefe37ec2e	25
1722939	meropenem 1000 MG Injection	SCD	3b952a55-6ef7-45c8-be21-16eefe37ec2e	25
1722934	meropenem 500 MG Injection	SCD	3b952a55-6ef7-45c8-be21-16eefe37ec2e	25
1722939	meropenem (as meropenem trihydrate) 1000 MG Injection	SY	3b952a55-6ef7-45c8-be21-16eefe37ec2e	25
1722934	meropenem (as meropenem trihydrate) 500 MG Injection	SY	3b952a55-6ef7-45c8-be21-16eefe37ec2e	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0264-3185-11	00264318511	24 CONTAINER in 1 CASE (0264-3185-11) / 50 mL in 1 CONTAINER	24 container	2015-04-30	0000-00-00	No	No	Current