Meropenem

Product NDC: 0781-3265
11-digit product format: 007813265
Labeler code: 0781
Product ID: 0781-3265_50365fe4-70db-487f-8259-42b54e85a2a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meropenem
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Sandoz Inc
Application: ANDA091201
Marketing category: ANDA
Marketing start: 2011-03-29
Marketing end: 0000-00-00
Substance: MEROPENEM
Active strength: 500 mg/10mL
Pharmacologic classes: Carbapenems [CS],Penem Antibacterial [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0781-3265		D	Discontinued by firm		2026-08-11
excluded package	package	0781-3265	0781-3265-95	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-3265-95	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-3265-95	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-3265-95	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-3265-95	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-3265-95	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-3265-95	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-3265-95	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-3265-95	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-3265-95	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-3265-95	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0781-3265-95	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0781-3265-95	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0781-3265-95	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0781-3265-95	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0781-3265-95	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A091201-001	MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION			2011-03-29
A091201-002	MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION			2011-03-29

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	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091201-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2011-03-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091201-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-29	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0781-3265-95	2021-01-07	C162847	48780-1	9d75b9d0-ee7b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Meropenem for Injection safely and effectively. See full prescribing information for Meropenem for Injection. Meropenem for Injection Initial U.S. Approval: 1996 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and other antibacterial drugs, Meropenem for Injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible b
0781-3265-95	2020-01-31	C162847	48780-1	9d75b9d0-ee7b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Meropenem for Injection safely and effectively. See full prescribing information for Meropenem for Injection. Meropenem for Injection Initial U.S. Approval: 1996 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and other antibacterial drugs, Meropenem for Injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-3265-80	EA - Each	0781-3265	51a28181-18a5-4265-9897-3adb3ccfb3b2	1	2012-07-24
0781-3265-95	EA - Each	0781-3265	bc31f5e0-240f-44df-8075-440b3e5aba9d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MEROPENEM	ACTIVE INGREDIENT	FV9J3JU8B1	MEROPENEM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]	17
MEROPENEM ANHYDROUS	ACTIVE MOIETY	YOP6PX0BAO	MEROPENEM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]	17
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	MEROPENEM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]	17