Ertapenem

Product NDC: 44647-051
11-digit product format: 446470051
Labeler code: 44647
Product ID: 44647-051_0b211a36-8d30-fb5e-e063-6294a90af3de
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ertapenem Sodium
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Savior Lifetec Corporation
Application: ANDA207647
Marketing category: ANDA
Marketing start: 2019-03-19
Substance: ERTAPENEM SODIUM
Active strength: 1 g/20mL
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
A207647-001	ERTAPENEM SODIUM	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP		2019-03-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207647-001	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	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207647-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2019-03-19	`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	A207647-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207647-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207647-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207647-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207647-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207647-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207647-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207647-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207647-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207647-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207647-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207647-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207647-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207647-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207647-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207647-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207647-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207647-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207647-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207647-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207647-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207647-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207647-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207647-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207647-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207647-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207647-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207647-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207647-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207647-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207647-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207647-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207647-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207647-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207647-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207647-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207647-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207647-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207647-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207647-001	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/20mL

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
c4da28cb-6725-4fa1-a7b0-e84f408fb36b	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44647-051-01	Ertapenem	20 mL in 1 VIAL	INJECTION	20		14
44647-051-10	Ertapenem	10 in 1 CARTON	INJECTION	10		14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44647-051	ERTAPENEM (ERTAPENEM SODIUM) INJECTION [SAVIOR LIFETEC CORPORATION]	14	Current NDC, Legacy NDC, 2 package rows	20231128_c4da28cb-6725-4fa1-a7b0-e84f408fb36b.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
Ertapenem	ERTAPENEM SODIUM	BluePoint Laboratories	8eccc96f-4b59-49ee-9997-365a24f59a24	2024-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207647 application number: ANDA207647
Ertapenem	ERTAPENEM SODIUM	Apotex Corp	468105b9-48b3-4477-82c7-e7fb92460e28	2023-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207647 application number: ANDA207647
Ertapenem	ERTAPENEM SODIUM	Savior Lifetec Corporation	c4da28cb-6725-4fa1-a7b0-e84f408fb36b	2023-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207647 application number: ANDA207647 ndc (product): 44647-051

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	c4da28cb-6725-4fa1-a7b0-e84f408fb36b	14
1734683	ertapenem 1000 MG Injection	SCD	c4da28cb-6725-4fa1-a7b0-e84f408fb36b	14
1734683	ertapenem (as ertapenem sodium 1.046 GM) Injection	SY	c4da28cb-6725-4fa1-a7b0-e84f408fb36b	14
1734683	ertapenem 1 GM Injection	SY	c4da28cb-6725-4fa1-a7b0-e84f408fb36b	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44647-051-01	44647005101	20 mL in 1 VIAL	20 ml					Historical
44647-051-10	44647005110	10 VIAL in 1 CARTON (44647-051-10) / 20 mL in 1 VIAL (44647-051-01)	10 vial	2019-03-19	0000-00-00	No	No	Current