Home NDC 54838-510 Oxybutynin Chloride
Product NDC 54838-510
11-digit product format 548380510
Labeler code 54838
Product ID 54838-510_693f3eb4-b7f1-420a-b813-ecd8e326882d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxybutynin Chloride
Dosage form SYRUP
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA074520
Marketing category ANDA
Marketing start 1996-03-29
Substance OXYBUTYNIN CHLORIDE
Active strength 5 mg/5mL
Pharmacologic classes Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
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 A074520-001 OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074520-001 AA
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 RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA 1996-03-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA 1996-03-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA 1996-03-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA 1996-03-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA 1996-03-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA 1996-03-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA 1996-03-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA 1996-03-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA 1996-03-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA 1996-03-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA 1996-03-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074520-001 OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP / ORAL AA RS 1996-03-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Oxybutynin Chloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYBUTYNIN CHLORIDE 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L9F3D9RENQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 863599 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 54838-510-80 Oxybutynin Chloride 473 mL in 1 BOTTLE, PLASTIC SYRUP 473 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Oxybutynin Chloride ACTIVE INGREDIENT L9F3D9RENQ OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] 16 Oxybutynin ACTIVE MOIETY K9P6MC7092 OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] 16 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] 16 FD&C Green No. 3 INACTIVE INGREDIENT 3P3ONR6O1S OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] 16 glycerin INACTIVE INGREDIENT PDC6A3C0OX OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] 16 methylparaben INACTIVE INGREDIENT A2I8C7HI9T OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] 16 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] 16 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] 16 sorbitol INACTIVE INGREDIENT 506T60A25R OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] 16 sucrose INACTIVE INGREDIENT C151H8M554 OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] 16 water INACTIVE INGREDIENT 059QF0KO0R OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54838-510 OXYBUTYNIN CHLORIDE SYRUP [LANNETT COMPANY, INC.] 24 Current NDC, Legacy NDC, 1 package rows 20250406_615f3d95-197c-4fec-b81f-c26449c93c3b.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 · 2 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 54838-510-80 54838051080 473 mL in 1 BOTTLE, PLASTIC (54838-510-80) 473 ml 1996-03-29 0000-00-00 No No Current