Meropenem

Product NDC: 0409-0222
11-digit product format: 004090222
Labeler code: 0409
Product ID: 0409-0222_2ad24c61-4908-4053-997a-9d0a9e6810dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meropenem
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: ANDA091404
Marketing category: ANDA
Marketing start: 2022-12-06
Substance: MEROPENEM
Active strength: 500 mg/10mL
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
A091404-001	MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-26
A091404-002	MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091404-001	AP
A091404-002	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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091404-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091404-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091404-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091404-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091404-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091404-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091404-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091404-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091404-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091404-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091404-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091404-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091404-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091404-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091404-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091404-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091404-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091404-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091404-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091404-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091404-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091404-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091404-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091404-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091404-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091404-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091404-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091404-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091404-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091404-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091404-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091404-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091404-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091404-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091404-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091404-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091404-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091404-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091404-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091404-002	AP	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEROPENEM	500 mg/10mL

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
e9b6555f-20a1-4415-bb80-3d034cfab95b	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
0409-0222-01	Meropenem	10 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	10		3
0409-0222-10	Meropenem	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-0222-01	EA - Each	0409-0222	54776273-328f-4057-b613-3eed72be1bef	1	2023-01-09
0409-0222-10	EA - Each	0409-0222	a3142e93-ffd8-49ed-8790-638ac8722dbe	1	2023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-0222	MEROPENEM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20241108_e9b6555f-20a1-4415-bb80-3d034cfab95b.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meropenem	MEROPENEM	Hospira, Inc.	e9b6555f-20a1-4415-bb80-3d034cfab95b	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091404 application number: ANDA091404 ndc (product): 0409-0222
Meropenem	MEROPENEM	Hospira, Inc.	092ebd9b-77a0-4877-afc3-dd8211730f71	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091404 application number: ANDA091404
Meropenem	MEROPENEM	Fresenius Kabi USA, LLC	12714f80-d6e5-4453-b66c-62f57c16ddfc	2021-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091404 application number: ANDA091404
Meropenem	MEROPENEM	Fresenius Kabi USA, LLC	7a68d899-2678-43a9-a9c1-ef8f916b562f	2021-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091404 application number: ANDA091404
Meropenem	MEROPENEM	Fresenius Kabi USA, LLC	185181e3-c004-4d61-b992-5df94fe57a90	2020-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091404 application number: ANDA091404

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	e9b6555f-20a1-4415-bb80-3d034cfab95b	3
1722934	meropenem 500 MG Injection	PSN	e9b6555f-20a1-4415-bb80-3d034cfab95b	3
1722939	meropenem 1000 MG Injection	SCD	e9b6555f-20a1-4415-bb80-3d034cfab95b	3
1722934	meropenem 500 MG Injection	SCD	e9b6555f-20a1-4415-bb80-3d034cfab95b	3
1722939	meropenem (as meropenem trihydrate) 1000 MG Injection	SY	e9b6555f-20a1-4415-bb80-3d034cfab95b	3
1722934	meropenem (as meropenem trihydrate) 500 MG Injection	SY	e9b6555f-20a1-4415-bb80-3d034cfab95b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-0222-01	00409022201	10 mL in 1 VIAL	10 ml					Historical
0409-0222-10	00409022210	10 VIAL in 1 CARTON (0409-0222-10) / 10 mL in 1 VIAL (0409-0222-01)	10 vial	2022-12-06	0000-00-00	No	No	Current