Home NDC 63323-366 Dimenhydrinate
Product NDC 63323-366
11-digit product format 633230366
Labeler code 63323
Product ID 63323-366_b3e3433d-c18b-4ed3-b2ba-1e550474ca33
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dimenhydrinate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA040519
Marketing category ANDA
Marketing start 2004-11-29
Substance DIMENHYDRINATE
Active strength 50 mg/mL
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 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 A040519-001 DIMENHYDRINATE DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23
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 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040519-001 DIMENHYDRINATE 50MG/ML INJECTABLE / INJECTION RS 2004-06-23 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Dimenhydrinate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMENHYDRINATE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JB937PER5C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309914 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 63323-366-00 Dimenhydrinate 1 mL in 1 VIAL INJECTION, SOLUTION 1 5 63323-366-01 Dimenhydrinate 25 in 1 TRAY INJECTION, SOLUTION 25 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIMENHYDRINATE ACTIVE INGREDIENT JB937PER5C DIMENHYDRINATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 DIMENHYDRINATE ACTIVE MOIETY JB937PER5C DIMENHYDRINATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH DIMENHYDRINATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB DIMENHYDRINATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DIMENHYDRINATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I DIMENHYDRINATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-366 DIMENHYDRINATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20250221_bc71539e-1a33-4709-8a24-c2894e8dbc1c.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 · 1 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 63323-366-00 63323036600 1 mL in 1 VIAL 1 ml Historical 63323-366-01 63323036601 25 VIAL in 1 TRAY (63323-366-01) / 1 mL in 1 VIAL (63323-366-00) 25 vial 2004-11-29 0000-00-00 No No Current