ERTAPENEM SODIUM

Product NDC: 16714-889
11-digit product format: 167140889
Labeler code: 16714
Product ID: 16714-889_b1a0c90d-c014-6561-5ab3-07e98e9fdfea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ertapenem
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: NorthStar RxLLC
Application: ANDA212040
Marketing category: ANDA
Marketing start: 2021-07-13
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
A212040-001	ERTAPENEM SODIUM	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP		2021-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212040-001	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	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212040-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2021-03-26	`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	A212040-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212040-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212040-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212040-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212040-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212040-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212040-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212040-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212040-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212040-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212040-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212040-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212040-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212040-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212040-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212040-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212040-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212040-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212040-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212040-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212040-001	AP	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212040-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212040-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212040-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212040-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212040-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212040-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212040-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212040-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212040-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212040-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212040-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212040-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212040-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212040-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: ERTAPENEM SODIUM
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
2398d418-6efc-b4d2-3265-936001df9b8b	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
16714-889-01	ERTAPENEM SODIUM	1 in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1		5
16714-889-10	ERTAPENEM SODIUM	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-889-01	EA - Each	16714-889	adcf31ab-b851-4b6b-8f6f-0b238dd3eeb7	1	2021-10-08
16714-889-10	EA - Each	16714-889	16bccce1-41b8-40c0-8513-0198f16169ac	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-889	ERTAPENEM SODIUM (ERTAPENEM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NORTHSTAR RXLLC]	4	Current NDC, Legacy NDC, 2 package rows	20241219_2398d418-6efc-b4d2-3265-936001df9b8b.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	NorthStar RxLLC	2398d418-6efc-b4d2-3265-936001df9b8b	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212040 application number: ANDA212040 ndc (product): 16714-889
Ertapenem	ERTAPENEM SODIUM	Fosun Pharma USA Inc	c398450c-2b72-86a4-e053-2995a90ad1f0	2024-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212040 application number: ANDA212040
Ertapenem	ERTAPENEM SODIUM	Gland Pharma Limited	f74cca2f-e775-4580-acae-3a0c47dd24d9	2022-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212040 application number: ANDA212040
ERTAPENEM SODIUM	ERTAPENEM	Dr.Reddys Laboratories Inc.,	32d9f095-ca39-7e22-6264-b54f2daaee57	2021-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212040 application number: ANDA212040

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2T90KE67L0	ERTAPENEM SODIUM	153773-82-1	ERTAPENEM SODIUM
G32F6EID2H	ERTAPENEM	153832-46-3	Ertapenem

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1734683	ertapenem sodium 1 GM Injection	PSN	2398d418-6efc-b4d2-3265-936001df9b8b	5
1734683	ertapenem 1000 MG Injection	SCD	2398d418-6efc-b4d2-3265-936001df9b8b	5
1734683	ertapenem (as ertapenem sodium 1.046 GM) Injection	SY	2398d418-6efc-b4d2-3265-936001df9b8b	5
1734683	ertapenem 1 GM Injection	SY	2398d418-6efc-b4d2-3265-936001df9b8b	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-889-01	16714088901	1 in 1 VIAL, SINGLE-DOSE					Historical
16714-889-10	16714088910	10 VIAL, SINGLE-DOSE in 1 CARTON (16714-889-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (16714-889-01)	2021-07-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ERTAPENEM SODIUM	NorthStar RxLLC \| Gland Pharma Limited	2025-12-24	HUMAN PRESCRIPTION DRUG LABEL	5