Diphenhydramine

Product NDC: 63323-664
11-digit product format: 633230664
Labeler code: 63323
Product ID: 63323-664_38e8f892-3aa1-473f-9906-8b7ee5d23e89
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA040466
Marketing category: ANDA
Marketing start: 2002-08-01
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 mg/mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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 1.

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 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040466-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2002-05-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040466-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diphenhydramine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1723740	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
921b9f64-1096-46db-866a-67f0f9ff6790	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-664-00	Diphenhydramine	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1	6
63323-664-01	Diphenhydramine	25 in 1 TRAY	INJECTION, SOLUTION	25	6
63323-664-16	Diphenhydramine	25 in 1 TRAY	INJECTION, SOLUTION	25	4
63323-664-41	Diphenhydramine	1 mL in 1 VIAL	INJECTION, SOLUTION	1	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-664-00	ML - Milliliter	63323-664	5b65cd96-e4fc-4893-9bfc-598e2314bfde	1	2020-08-06
63323-664-01	ML - Milliliter	63323-664	dd6634b3-49ca-48c5-82b7-6296c47336eb	1	2012-07-24
63323-664-16	ML - Milliliter	63323-664	51a026f0-e2e5-45c4-9a3a-7e8c5c7853c5	1	2016-02-04
63323-664-41	ML - Milliliter	63323-664	681f1020-2f3c-4f9e-a526-ae737a575f0c	1	2020-06-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
diphenhydramine hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	1
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
diphenhydramine	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-664	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20250302_fc574e74-1fdc-4a61-a1ed-492ae43faed2.zip
63323-664	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20241019_921b9f64-1096-46db-866a-67f0f9ff6790.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 · 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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1723740	diphenhydrAMINE HCl 50 MG in 1 ML Injection	PSN	50df93bf-fe72-48f6-a02e-ea9a313d47c2	12
1723740	1 ML diphenhydramine hydrochloride 50 MG/ML Injection	SCD	50df93bf-fe72-48f6-a02e-ea9a313d47c2	12
1723740	diphenhydramine HCl 50 MG per 1 ML Injection	SY	50df93bf-fe72-48f6-a02e-ea9a313d47c2	12
1723740	diphenhydrAMINE HCl 50 MG in 1 ML Injection	PSN	fc574e74-1fdc-4a61-a1ed-492ae43faed2	6
1723740	1 ML diphenhydramine hydrochloride 50 MG/ML Injection	SCD	fc574e74-1fdc-4a61-a1ed-492ae43faed2	6
1723740	diphenhydramine HCl 50 MG per 1 ML Injection	SY	fc574e74-1fdc-4a61-a1ed-492ae43faed2	6
1723740	diphenhydrAMINE HCl 50 MG in 1 ML Injection	PSN	7b9ed8ef-ce21-19e7-e053-2a91aa0a81be	4
1723740	diphenhydrAMINE HCl 50 MG in 1 ML Injection	PSN	921b9f64-1096-46db-866a-67f0f9ff6790	4
1723740	diphenhydrAMINE HCl 50 MG in 1 ML Injection	PSN	9713d8ee-6ab2-2fdf-e053-2a95a90a9e19	4
1723740	1 ML diphenhydramine hydrochloride 50 MG/ML Injection	SCD	7b9ed8ef-ce21-19e7-e053-2a91aa0a81be	4
1723740	1 ML diphenhydramine hydrochloride 50 MG/ML Injection	SCD	921b9f64-1096-46db-866a-67f0f9ff6790	4
1723740	1 ML diphenhydramine hydrochloride 50 MG/ML Injection	SCD	9713d8ee-6ab2-2fdf-e053-2a95a90a9e19	4
1723740	diphenhydramine HCl 50 MG per 1 ML Injection	SY	7b9ed8ef-ce21-19e7-e053-2a91aa0a81be	4
1723740	diphenhydramine HCl 50 MG per 1 ML Injection	SY	921b9f64-1096-46db-866a-67f0f9ff6790	4
1723740	diphenhydramine HCl 50 MG per 1 ML Injection	SY	9713d8ee-6ab2-2fdf-e053-2a95a90a9e19	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-664-00	63323066400	1 mL in 1 VIAL, SINGLE-DOSE	1 ml					Historical
63323-664-01	63323066401	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-664-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-664-00)		2002-08-01	0000-00-00	No	No	Current
63323-664-16	63323066416	25 VIAL in 1 TRAY (63323-664-16) / 1 mL in 1 VIAL (63323-664-41)	25 vial	2002-08-01	0000-00-00	No	No	Current
63323-664-41	63323066441	1 mL in 1 VIAL	1 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP 50 mg PER mL 1mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2026-05-19	HUMAN PRESCRIPTION DRUG LABEL	4
DiphenhydrAMINE Hydrochloride Injection, USP	Cardinal Health 107, LLC	2026-05-15	HUMAN PRESCRIPTION DRUG LABEL	13
DiphenhydrAMINE Hydrochloride Injection, USP	Fresenius Kabi USA, LLC	2025-02-21	HUMAN PRESCRIPTION DRUG LABEL	6
DiphenhydrAMINE Hydrochloride Injection, USP	REMEDYREPACK INC.	2024-11-22	HUMAN PRESCRIPTION DRUG LABEL	5
DiphenhydrAMINE Hydrochloride Injection, USP	Fresenius Kabi USA, LLC	2024-10-14	HUMAN PRESCRIPTION DRUG LABEL	4
DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP 50mg/mL 1mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2022-12-10	HUMAN PRESCRIPTION DRUG LABEL	4
DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP	General Injectables and Vaccines, Inc	2019-12-31	HUMAN PRESCRIPTION DRUG LABEL	4