MEROPENEM

Product NDC: 44647-033
Requested package NDC: 44647-033-10
11-digit product format: 446470033
Labeler code: 44647
Product ID: 44647-033_4462e33b-7723-b7b4-e063-6294a90a981a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MEROPENEM
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Savior Lifetec Corporation
Application: ANDA206086
Marketing category: ANDA
Marketing start: 2016-04-19
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

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 · 14 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A206086-001	MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2016-04-19
A206086-002	MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2016-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206086-001	AP
A206086-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206086-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206086-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	2016-04-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206086-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206086-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206086-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206086-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206086-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206086-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206086-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206086-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206086-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206086-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206086-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206086-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206086-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206086-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206086-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206086-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206086-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206086-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206086-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206086-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206086-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206086-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206086-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206086-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206086-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206086-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206086-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206086-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206086-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206086-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206086-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206086-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206086-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206086-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206086-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206086-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206086-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206086-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206086-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206086-002	AP	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
31dd2160-7dbd-51fa-e054-00144ff88e88	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
44647-033-10	2025-12-03	C162847	48780-1	f386c649-991c-0266-e053-dadaa90a7c1a	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
44647-033-10	2023-01-30	C162847	48780-1	f386c649-991c-0266-e053-dadaa90a7c1a	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44647-033-01	MEROPENEM	30 mL in 1 VIAL	INJECTION	30		5
44647-033-10	MEROPENEM	10 in 1 CARTON	INJECTION	10		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44647-033	MEROPENEM INJECTION [SAVIOR LIFETEC CORPORATION]	2	Current NDC, Legacy NDC, 2 package rows	20160812_31dd2160-7dbd-51fa-e054-00144ff88e88.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MEROPENEM	MEROPENEM	Savior Lifetec Corporation	31dd2160-7dbd-51fa-e054-00144ff88e88	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206086 application number: ANDA206086 ndc (package): 44647-033-10 ndc (product): 44647-033 ndc11 (package): 44647003310
MEROPENEM	MEROPENEM	Sandoz Inc	0d37e43b-ff8d-495d-b9af-4fd5fce53d56	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206086 application number: ANDA206086
MEROPENEM	MEROPENEM	Civica, Inc	b0075b72-c3cc-f844-e053-2a95a90a417f	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206086 application number: ANDA206086

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	31dd2160-7dbd-51fa-e054-00144ff88e88	5
1722934	meropenem 500 MG Injection	PSN	31dd2160-7dbd-51fa-e054-00144ff88e88	5
1722939	meropenem 1000 MG Injection	SCD	31dd2160-7dbd-51fa-e054-00144ff88e88	5
1722934	meropenem 500 MG Injection	SCD	31dd2160-7dbd-51fa-e054-00144ff88e88	5
1722939	meropenem (as meropenem trihydrate) 1000 MG Injection	SY	31dd2160-7dbd-51fa-e054-00144ff88e88	5
1722934	meropenem (as meropenem trihydrate) 500 MG Injection	SY	31dd2160-7dbd-51fa-e054-00144ff88e88	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44647-033-10	44647003310	10 VIAL in 1 CARTON (44647-033-10) / 30 mL in 1 VIAL (44647-033-01)	10 vial	2016-04-19	0000-00-00	No	No	Current