Application 212040

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERTAPENEM SODIUM	ERTAPENEM SODIUM	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 1GM BASE/VIAL	No	No

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…`

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 ndc (product): 72266-159
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 ndc (product): 68083-351
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 ndc (product): 43598-901

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-889	ERTAPENEM SODIUM	Ertapenem	NorthStar RxLLC	ANDA	Current
16714-889	ERTAPENEM SODIUM	Ertapenem	NorthStar RxLLC	ANDA	Current
43598-901	ERTAPENEM SODIUM	Ertapenem	Dr.Reddy	ANDA	Current
43598-901	ERTAPENEM SODIUM	Ertapenem	Dr.Reddy	ANDA	Current
43598-901	ERTAPENEM SODIUM	Ertapenem	Dr.Reddy	ANDA	Current
68083-351	Ertapenam	Ertapenam Sodium	Gland Pharma Limited	ANDA	Current
68083-351	Ertapenem	Ertapenem Sodium	Gland Pharma Limited	ANDA	Current
68083-351	Ertapenem	Ertapenem Sodium	Gland Pharma Limited	ANDA	Current
72266-159	Ertapenam	Ertapenam Sodium	Fosun Pharma USA Inc	ANDA	Current
72266-159	Ertapenem	Ertapenem Sodium	Fosun Pharma USA Inc	ANDA	Current
72266-159	Ertapenem	Ertapenem Sodium	Fosun Pharma USA Inc	ANDA	Current
72266-159	Ertapenem	Ertapenem Sodium	Fosun Pharma USA Inc	ANDA	Current
72266-159	Ertapenem	Ertapenem Sodium	Fosun Pharma USA Inc	ANDA	Current