FDA.reportPublic FDA data

Application 080817

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEINJECTABLE;INJECTION50MG/MLNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080817-002DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A080817-002AP

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A080817-002AP1c2088c7a36db…
2026-09-14 22:38:342026-08A080817-002AP184e616aacf4f…
2026-08-18 06:07:402026-07A080817-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080817-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080817-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A080817-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080817-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080817-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080817-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080817-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080817-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080817-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080817-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080817-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080817-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080817-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080817-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080817-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080817-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080817-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080817-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080817-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080817-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080817-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A080817-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080817-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080817-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080817-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A080817-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A080817-002AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080817-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080817-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080817-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080817-002AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080817-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080817-002AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080817-002AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A080817-002AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A080817-002AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080817-002AP13a93d1ddd44b…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDESportpharm LLCe5af2dd2-cc91-46c7-bdb9-97a7cdddcb692026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLCd32d074a-f1b6-4a9a-8e10-e19f0e67c61b2026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
ndc (product): 55154-5102
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEA-S Medication Solutionseedb421c-0020-4e5f-8b09-26a1cbabb6812026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
ndc (product): 50090-0878
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEA-S Medication Solutions5af966ae-535b-492b-ba2c-eeb4e40be9592026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
ndc (product): 50090-1841
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEREMEDYREPACK INC.62edde3d-b41b-40fc-ac18-b749035de8312026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
ndc (product): 70518-1082
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHenry Schein, Inc.af972e71-62ab-40c6-925a-cbcb4d6720a42025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
ndc (product): 0404-9851
Diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.829bbcbf-fb27-4484-aff6-a7e7467670af2025-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.ec691492-a295-4b48-a1a3-5824931efa972024-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
ndc (product): 0641-0376
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co. LLC, DBA Health First738f2ce3-520c-b3a2-e053-2a91aa0af3242024-02-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
ndc (product): 51662-1219
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLC6671c8d0-1f5d-0d77-e053-2a91aa0a75852023-04-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
ndc (product): 71872-7005

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9851Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideHenry Schein, Inc.ANDACurrent
0404-9851Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideHenry Schein, Inc.ANDACurrent
0641-0376Diphenhydramine Hydrochloridediphenhydramine hydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-0376Diphenhydramine Hydrochloridediphenhydramine hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
42254-190Diphenhydramine Hydrochloridediphenhydramine hydrochlorideRebel Distributors CorpANDACurrent
50090-0878Diphenhydramine Hydrochloridediphenhydramine hydrochlorideA-S Medication SolutionsANDACurrent
50090-1841Diphenhydramine Hydrochloridediphenhydramine hydrochlorideA-S Medication SolutionsANDACurrent
50090-1841Diphenhydramine Hydrochloridediphenhydramine hydrochlorideA-S Medication SolutionsANDACurrent
50090-1841Diphenhydramine Hydrochloridediphenhydramine hydrochlorideA-S Medication SolutionsANDACurrent
51662-1219DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co. LLC, DBA Health FirstANDACurrent
51662-1219DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co. LLC, DBA Health FirstANDACurrent
51662-1219DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co. LLC, DBA Health FirstANDACurrent
51662-1219DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co. LLC, DBA Health FirstANDACurrent
52584-376Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-376Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-376Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-376Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-376Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-376Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-376Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
55045-3683Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideDispensing Solutions, Inc.ANDACurrent
55154-5102Diphenhydramine Hydrochloridediphenhydramine hydrochlorideCardinal Health 107, LLCANDACurrent
55154-5102Diphenhydramine Hydrochloridediphenhydramine hydrochlorideCardinal HealthANDACurrent
55154-5102Diphenhydramine Hydrochloridediphenhydramine hydrochlorideCardinal HealthANDACurrent
55154-5102Diphenhydramine Hydrochloridediphenhydramine hydrochlorideCardinal HealthANDACurrent
55154-5102Diphenhydramine Hydrochloridediphenhydramine hydrochlorideCardinal HealthANDACurrent
55154-5102Diphenhydramine Hydrochloridediphenhydramine hydrochlorideCardinal HealthANDACurrent
64725-0376Diphenhydramine Hydrochloridediphenhydramine hydrochlorideTYA PharmaceuticalsANDACurrent
68071-1786Diphenhydramine Hydrochloridediphenhydramine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70385-2007Diphenhydramine Hydrochloridediphenhydramine hydrochlorideSina Health IncANDACurrent
70518-1082Diphenhydramine Hydrochloridediphenhydramine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1082Diphenhydramine Hydrochloridediphenhydramine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1082Diphenhydramine Hydrochloridediphenhydramine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1082Diphenhydramine Hydrochloridediphenhydramine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1082Diphenhydramine Hydrochloridediphenhydramine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1082Diphenhydramine Hydrochloridediphenhydramine hydrochlorideREMEDYREPACK INC.ANDACurrent
71872-7005Diphenhydramine Hydrochloridediphenhydramine hydrochlorideMedical Purchasing Solutions, LLCANDACurrent
71872-7005Diphenhydramine Hydrochloridediphenhydramine hydrochlorideMedical Purchasing Solutions, LLCANDACurrent