Meropenem

Product NDC: 70278-103
11-digit product format: 702780103
Labeler code: 70278
Product ID: 70278-103_eed23a09-bc93-c40b-e053-2a95a90a4a1f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meropenem
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Daewoong America Inc.
Application: ANDA204854
Marketing category: ANDA
Marketing start: 2016-10-08
Marketing end: 0000-00-00
Substance: MEROPENEM
Active strength: 500 mg/20mL
Pharmacologic classes: Carbapenems [CS], Penem Antibacterial [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	70278-103		D	Discontinued by firm		2026-08-11
excluded package	package	70278-103	70278-103-02	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	70278-103-02	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	70278-103-02	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	70278-103-02	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	70278-103-02	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	70278-103-02	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	70278-103-02	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	70278-103-02	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	70278-103-02	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	70278-103-02	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	70278-103-02	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	70278-103-02	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	70278-103-02	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70278-103-02	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70278-103-02	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70278-103-02	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
A204854-001	MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION			2015-12-18
A204854-002	MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION			2015-12-18

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	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION		2015-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION		2015-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION		2015-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION		2015-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION		2015-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION		2015-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION		2015-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION		2015-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION		2015-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION		2015-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION		2015-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION		2015-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION		2015-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION		2015-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION		2015-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION		2015-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION		2015-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION		2015-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION		2015-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION		2015-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION		2015-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION		2015-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION		2015-12-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION		2015-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION		2015-12-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION		2015-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION		2015-12-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION		2015-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2015-12-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2015-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2015-12-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2015-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2015-12-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2015-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2015-12-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2015-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2015-12-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2015-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204854-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2015-12-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204854-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2015-12-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204854-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204854-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204854-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204854-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204854-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204854-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204854-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204854-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204854-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204854-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204854-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204854-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204854-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204854-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204854-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204854-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204854-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204854-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204854-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204854-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204854-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204854-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204854-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204854-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204854-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204854-002	AP	1	`ea99ee380514…`
2024-02-18 07:12 UTC	2024-02	A204854-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204854-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204854-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204854-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204854-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204854-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204854-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204854-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204854-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204854-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204854-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204854-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204854-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204854-002	AP	1	`053a50430f4f…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70278-103-02	2024-06-12	C162847	48780-1	1030e364-fc27-111a-e063-dadaa90a10e2	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, for intravenous use Initial U.S. Approval: 1996
70278-103-02	2024-01-30	C162847	48780-1	1030e364-fc27-111a-e063-dadaa90a10e2	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, for intravenous use Initial U.S. Approval: 1996

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70278-103-02	70278010302	10 VIAL in 1 CARTON (70278-103-02) > 20 mL in 1 VIAL (70278-103-01)	10 vial	2016-10-08	0000-00-00	No	No	Current