Ertapenem

Product NDC: 63323-823
11-digit product format: 633230823
Labeler code: 63323
Product ID: 63323-823_8a08dc4b-9129-4b04-b586-19ca10abeafb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ertapenem Sodium
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA208790
Marketing category: ANDA
Marketing start: 2019-10-10
Substance: ERTAPENEM SODIUM
Active strength: 1 g/1
Pharmacologic classes: Carbapenems [CS], Penem Antibacterial [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208790-001	ERTAPENEM SODIUM	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP		2018-04-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208790-001	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 2 · 42 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
2026-08-18 06:07:40	2026-07	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208790-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208790-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208790-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208790-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208790-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208790-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208790-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208790-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208790-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208790-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208790-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208790-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208790-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208790-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208790-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208790-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208790-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208790-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208790-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208790-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208790-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208790-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208790-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208790-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208790-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208790-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208790-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208790-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208790-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208790-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208790-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208790-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208790-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208790-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208790-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208790-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208790-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208790-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208790-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208790-001	AP	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ERTAPENEM SODIUM	1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2T90KE67L0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1734683	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
666c9f33-ea9e-4667-b8bd-f8b1b6b6be51	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
aa4e6ef0-aff8-b16d-a7b0-a1baf91ab629	Product name	6	20250623
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63323-823-01	Ertapenem	1 in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1		4
63323-823-20	Ertapenem	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-823-01	EA - Each	63323-823	642146af-4120-46ff-9719-cb20702451ab	1	2019-12-10
63323-823-20	EA - Each	63323-823	680f86c0-b2e8-4cd4-953a-616964fb4132	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-823	ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20221111_666c9f33-ea9e-4667-b8bd-f8b1b6b6be51.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ertapenem sodium	ERTAPENEM SODIUM	Hikma Pharmaceuticals USA, Inc.	a400707f-763f-43f6-989e-0d2569d822d8	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208790 application number: ANDA208790
Ertapenem	ERTAPENEM	Hospira, Inc.	178a0356-4f6c-47fb-9913-f325a3c72f7b	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208790 application number: ANDA208790
Ertapenem	ERTAPENEM SODIUM	Fresenius Kabi USA, LLC	666c9f33-ea9e-4667-b8bd-f8b1b6b6be51	2022-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208790 application number: ANDA208790 ndc (product): 63323-823
ertapenem	ERTAPENEM	WG Critical Care, LLC	cf3cfa6b-211c-452b-b18b-e462b21e6909	2022-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208790 application number: ANDA208790

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2T90KE67L0	ERTAPENEM SODIUM	153773-82-1	ERTAPENEM SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1734683	ertapenem sodium 1 GM Injection	PSN	666c9f33-ea9e-4667-b8bd-f8b1b6b6be51	4
1734683	ertapenem 1000 MG Injection	SCD	666c9f33-ea9e-4667-b8bd-f8b1b6b6be51	4
1734683	ertapenem (as ertapenem sodium 1.046 GM) Injection	SY	666c9f33-ea9e-4667-b8bd-f8b1b6b6be51	4
1734683	ertapenem 1 GM Injection	SY	666c9f33-ea9e-4667-b8bd-f8b1b6b6be51	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-823-01	63323082301	1 in 1 VIAL, SINGLE-DOSE					Historical
63323-823-20	63323082320	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-823-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (63323-823-01)	2019-10-10	0000-00-00	No	No	Current