Meropenem

Product NDC: 68001-324
Requested package NDC: 68001-324-57
11-digit product format: 680010324
Labeler code: 68001
Product ID: 68001-324_45bbbbfc-a4d7-c7ed-e063-6294a90aca41
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meropenem
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: BluePoint Laboratories
Application: ANDA205883
Marketing category: ANDA
Marketing start: 2017-04-30
Substance: MEROPENEM
Active strength: 1 g/30mL
Pharmacologic classes: Carbapenems [CS], Penem Antibacterial [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68001-324	68001-324-57	D	Discontinued by firm		2026-08-03

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
A205883-001	MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2016-04-12
A205883-002	MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2016-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205883-001	AP
A205883-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205883-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205883-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-12	`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	A205883-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205883-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205883-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205883-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205883-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205883-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205883-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205883-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205883-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205883-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205883-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205883-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205883-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205883-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205883-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205883-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205883-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205883-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205883-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205883-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205883-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205883-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205883-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205883-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205883-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205883-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205883-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205883-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205883-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205883-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205883-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205883-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205883-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205883-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205883-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205883-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205883-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205883-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205883-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205883-002	AP	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meropenem	MEROPENEM	BluePoint Laboratories	ca5f501c-6520-4d09-aae2-4f5db74d468f	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205883 application number: ANDA205883 ndc (package): 68001-324-57 ndc (product): 68001-324 ndc11 (package): 68001032457
Meropenem	MEROPENEM	Amneal Pharmaceuticals LLC	a456013b-b20e-4b29-b2f9-06f18f1ea6bd	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205883 application number: ANDA205883

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEROPENEM	1 g/30mL

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
ca5f501c-6520-4d09-aae2-4f5db74d468f	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
68001-324-57	Meropenem	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10		7
68001-324-58	Meropenem	30 mL in 1 VIAL, GLASS	INJECTION, POWDER, FOR SOLUTION	30		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-324-57	EA - Each	68001-324	d5a728ce-db76-43f5-be40-fdc22ca7916f	1	2017-07-07
68001-324-58	EA - Each	68001-324	59e6d549-9786-4ffa-acb0-7dc3b203d347	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-324	MEROPENEM INJECTION, POWDER, FOR SOLUTION [BLUEPOINT LABORATORIES]	6	Current NDC, Legacy NDC, 2 package rows	20191023_ca5f501c-6520-4d09-aae2-4f5db74d468f.zip

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	ca5f501c-6520-4d09-aae2-4f5db74d468f	7
1722934	meropenem 500 MG Injection	PSN	ca5f501c-6520-4d09-aae2-4f5db74d468f	7
1722939	meropenem 1000 MG Injection	SCD	ca5f501c-6520-4d09-aae2-4f5db74d468f	7
1722934	meropenem 500 MG Injection	SCD	ca5f501c-6520-4d09-aae2-4f5db74d468f	7
1722939	meropenem (as meropenem trihydrate) 1000 MG Injection	SY	ca5f501c-6520-4d09-aae2-4f5db74d468f	7
1722934	meropenem (as meropenem trihydrate) 500 MG Injection	SY	ca5f501c-6520-4d09-aae2-4f5db74d468f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-324-57	68001032457	10 VIAL, GLASS in 1 CARTON (68001-324-57) > 30 mL in 1 VIAL, GLASS (68001-324-58)	2017-04-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meropenem	BluePoint Laboratories \| Amneal Biosciences \| Savior Lifetec Corporation Tainan Branch Injection Plant	2025-12-12	HUMAN PRESCRIPTION DRUG LABEL	7