Meropenem

Product NDC: 25021-160
11-digit product format: 250210160
Labeler code: 25021
Product ID: 25021-160_88e3a173-e663-4d73-bcc8-0096bdc4aff4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meropenem
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA216424
Marketing category: ANDA
Marketing start: 2025-11-01
Substance: MEROPENEM
Active strength: 500 mg/20mL
Pharmacologic classes: Carbapenems [CS], Penem Antibacterial [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A216424-001	MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2024-07-22
A216424-002	MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2024-07-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216424-001	AP
A216424-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216424-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216424-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216424-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216424-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216424-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216424-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216424-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216424-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216424-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216424-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216424-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216424-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216424-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216424-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216424-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216424-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216424-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216424-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216424-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216424-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216424-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216424-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216424-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216424-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-07-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216424-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216424-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216424-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216424-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216424-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216424-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216424-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216424-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216424-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216424-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216424-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216424-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216424-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216424-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216424-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216424-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216424-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216424-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216424-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216424-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216424-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216424-002	AP	1	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216424-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216424-002	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Meropenem
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEROPENEM	500 mg/20mL

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
e8848f4a-bca9-4978-b0a1-38483fd4d639	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
25021-160-20	Meropenem	20 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	20		2
25021-160-20	Meropenem	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-160-20	EA - Each	25021-160	251f3275-9d2e-482e-8f87-9bde5781dd85	1	2025-11-13

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meropenem	MEROPENEM	Sagent Pharmaceuticals	e8848f4a-bca9-4978-b0a1-38483fd4d639	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216424 application number: ANDA216424 ndc (product): 25021-160
Meropenem	MEROPENEM	Qilu Antibiotics Pharmaceutical Co., Ltd.	1f9591ed-3a6c-422e-b1be-7b3e4fe5bf3c	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216424 application number: ANDA216424
Meropenem	MEROPENEM	Hikma Pharmaceuticals USA Inc.	d54fdbad-ca93-467c-92d7-c1bd88f3bbe3	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216424 application number: ANDA216424

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	e8848f4a-bca9-4978-b0a1-38483fd4d639	2
1722934	meropenem 500 MG Injection	PSN	e8848f4a-bca9-4978-b0a1-38483fd4d639	2
1722939	meropenem 1000 MG Injection	SCD	e8848f4a-bca9-4978-b0a1-38483fd4d639	2
1722934	meropenem 500 MG Injection	SCD	e8848f4a-bca9-4978-b0a1-38483fd4d639	2
1722939	meropenem (as meropenem trihydrate) 1000 MG Injection	SY	e8848f4a-bca9-4978-b0a1-38483fd4d639	2
1722934	meropenem (as meropenem trihydrate) 500 MG Injection	SY	e8848f4a-bca9-4978-b0a1-38483fd4d639	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
25021-160-20	25021016020	10 VIAL in 1 CARTON (25021-160-20) / 20 mL in 1 VIAL	10 vial	2025-11-01	No	No	Current