Application 204842

Type: ANDA
Sponsor: HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.25%	No	No
002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.5%	No	No
003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.75%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11
A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11
A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204842-001	AP
A204842-002	AP
A204842-003	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 3 · 102 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
2026-02-19 14:30 UTC	2026-02	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204842-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204842-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204842-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204842-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204842-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204842-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204842-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204842-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204842-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204842-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204842-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204842-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204842-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204842-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204842-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204842-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204842-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204842-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204842-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204842-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204842-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204842-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204842-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204842-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204842-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204842-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204842-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204842-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204842-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204842-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204842-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204842-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204842-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204842-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204842-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204842-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204842-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204842-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204842-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204842-001	AP	1	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	8815c8c6-eed8-4afe-a5c1-44d2194025a3	2024-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204842 application number: ANDA204842 ndc (product): 0143-9331 ndc (product): 0143-9332 ndc (product): 0143-9334 ndc (product): 0143-9330 ndc (product): 0143-9335 ndc (product): 0143-9333
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Asclemed USA, Inc.	f37a19ad-5e69-44a8-947b-847df2106fb3	2023-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204842 application number: ANDA204842

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9330	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9331	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9332	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9333	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9334	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9335	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current