Ertapenem

Product NDC: 25021-199
11-digit product format: 250210199
Labeler code: 25021
Product ID: 25021-199_0a3ba6c5-088b-4c94-8ece-b76034ecccb8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ertapenem Sodium
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA218067
Marketing category: ANDA
Marketing start: 2025-08-15
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
A218067-001	ERTAPENEM SODIUM	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP		2024-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218067-001	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.

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	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A218067-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218067-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218067-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218067-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218067-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218067-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218067-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218067-001	AP	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218067-001	AP	1	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218067-001	AP	1	`a50c72e98297…`

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
39bd4d41-36f8-4826-a733-a5ad1a531c02	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	SPL version
25021-199-20	Ertapenem	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10	1
25021-199-20	Ertapenem	1 in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	1	1
25021-199-66	Ertapenem	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10	1
25021-199-66	Ertapenem	1 in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	1	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-199-20	EA - Each	25021-199	54ecae08-ae31-459d-9a04-ab433d7addaf	1	2025-09-12
25021-199-66	EA - Each	25021-199	66dee059-cc30-4b8b-bd59-36eb90bec6a3	1	2026-02-05

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	ERTAPENEM SODIUM	Sagent Pharmaceuticals	124775ed-1271-4581-be52-b7a08c91283d	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218067 application number: ANDA218067 ndc (product): 25021-199
Ertapenem	ERTAPENEM SODIUM	Qilu Antibiotics Pharmaceutical Co., Ltd.	44496f7c-8407-4765-9cd6-1daa619a6db6	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218067 application number: ANDA218067
Ertapenem	ERTAPENEM SODIUM	Sagent Pharmaceuticals	39bd4d41-36f8-4826-a733-a5ad1a531c02	2025-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218067 application number: ANDA218067 ndc (product): 25021-199
Ertapenem	ERTAPENEM SODIUM	Hikma Pharmaceuticals USA Inc.	b88c0709-33fe-47db-8ae8-8bad6692d5d5	2024-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218067 application number: ANDA218067

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	124775ed-1271-4581-be52-b7a08c91283d	1
1734683	ertapenem sodium 1 GM Injection	PSN	39bd4d41-36f8-4826-a733-a5ad1a531c02	1
1734683	ertapenem 1000 MG Injection	SCD	124775ed-1271-4581-be52-b7a08c91283d	1
1734683	ertapenem 1000 MG Injection	SCD	39bd4d41-36f8-4826-a733-a5ad1a531c02	1
1734683	ertapenem (as ertapenem sodium 1.046 GM) Injection	SY	124775ed-1271-4581-be52-b7a08c91283d	1
1734683	ertapenem (as ertapenem sodium 1.046 GM) Injection	SY	39bd4d41-36f8-4826-a733-a5ad1a531c02	1
1734683	ertapenem 1 GM Injection	SY	124775ed-1271-4581-be52-b7a08c91283d	1
1734683	ertapenem 1 GM Injection	SY	39bd4d41-36f8-4826-a733-a5ad1a531c02	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
25021-199-20	25021019920	10 VIAL in 1 CARTON (25021-199-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	10 vial	2025-08-15	No	No	Current
25021-199-66	25021019966	10 VIAL in 1 CARTON (25021-199-66) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	10 vial	2026-01-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ertapenem	Sagent Pharmaceuticals	2026-01-09	HUMAN PRESCRIPTION DRUG LABEL	1
Ertapenem	Sagent Pharmaceuticals	2025-08-17	HUMAN PRESCRIPTION DRUG LABEL	1