Application 040466

Type: ANDA
Sponsor: APP PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/ML	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
A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2002-05-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040466-001	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	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`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	A040466-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040466-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040466-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040466-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040466-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040466-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040466-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040466-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040466-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040466-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040466-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040466-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040466-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040466-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040466-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040466-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040466-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040466-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040466-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040466-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040466-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040466-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040466-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040466-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040466-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040466-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040466-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040466-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040466-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040466-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040466-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040466-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040466-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040466-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040466-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040466-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040466-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040466-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040466-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040466-001	AP	1	`e64feba35796…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9713d8ee-6ab2-2fdf-e053-2a95a90a9e19	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040466 application number: ANDA040466 ndc (product): 51662-1374
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 107, LLC	50df93bf-fe72-48f6-a02e-ea9a313d47c2	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040466 application number: ANDA040466 ndc (product): 55154-9363
Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	f4f0c26b-dad0-47a1-a9e7-6558c11254c0	2025-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040466 application number: ANDA040466
Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	fc574e74-1fdc-4a61-a1ed-492ae43faed2	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040466 application number: ANDA040466 ndc (product): 63323-664
Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	921b9f64-1096-46db-866a-67f0f9ff6790	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040466 application number: ANDA040466 ndc (product): 63323-664
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	7b9ed8ef-ce21-19e7-e053-2a91aa0a81be	2022-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040466 application number: ANDA040466 ndc (product): 51662-1348

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1348	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1348	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1348	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1348	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1374	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1374	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1374	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-664	Diphenhydramine Hydrochloride	Diphenhydramine Hydrochloride	General Injectables and Vaccines, Inc	ANDA	Current
52584-664	Diphenhydramine Hydrochloride	Diphenhydramine Hydrochloride	General Injectables and Vaccines, Inc	ANDA	Current
55154-9363	Diphenhydramine Hydrochloride	diphenhydramine hydrochloride	Cardinal Health	ANDA	Current
55154-9363	Diphenhydramine Hydrochloride	diphenhydramine hydrochloride	Cardinal Health 107, LLC	ANDA	Current
55154-9363	Diphenhydramine Hydrochloride	diphenhydramine hydrochloride	Cardinal Health	ANDA	Current
55154-9363	Diphenhydramine Hydrochloride	diphenhydramine hydrochloride	Cardinal Health	ANDA	Current
63323-664	Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-664	Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-664	Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-664	Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-664	Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-664	Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
7668	ORIG	2003-04-09