Home NDC 42571-337 DIPHENHYDRAMINE
Product NDC 42571-337
11-digit product format 425710337
Labeler code 42571
Product ID 42571-337_4c46492b-00c4-8ee4-e063-6294a90a6914
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Micro Labs Limited
Application ANDA205723
Marketing category ANDA
Marketing start 2019-12-10
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 2027-12-31
Current FDA listing Yes 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 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205723-001 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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205723-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2018-08-22 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DIPHENHYDRAMINE
Listing expiration 2027-12-31 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42571-337-56 DIPHENHYDRAMINE 1 in 1 CARTON INJECTION, SOLUTION 1 11 42571-337-56 DIPHENHYDRAMINE 1 mL in 1 VIAL INJECTION, SOLUTION 1 11 42571-337-78 DIPHENHYDRAMINE 1 mL in 1 VIAL INJECTION, SOLUTION 1 11 42571-337-78 DIPHENHYDRAMINE 5 in 1 CARTON INJECTION, SOLUTION 5 11 42571-337-87 DIPHENHYDRAMINE 25 in 1 CARTON INJECTION, SOLUTION 25 11 42571-337-95 DIPHENHYDRAMINE 1 mL in 1 VIAL INJECTION, SOLUTION 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-337 DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [MICRO LABS LIMITED] 9 Current NDC, Legacy NDC, 6 package rows 20221129_a1110433-498a-48cb-ac79-5732fd4f8fba.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42571-337-56 42571033756 1 VIAL in 1 CARTON (42571-337-56) / 1 mL in 1 VIAL 1 vial 2026-03-05 No No Current 42571-337-78 42571033778 5 VIAL in 1 CARTON (42571-337-78) / 1 mL in 1 VIAL 5 vial 2026-03-03 No No Current 42571-337-87 42571033787 25 VIAL in 1 CARTON (42571-337-87) / 1 mL in 1 VIAL (42571-337-95) 25 vial 2019-12-10 0000-00-00 No No Current 42571-337-95 42571033795 1 mL in 1 VIAL 1 ml Historical