Home NDC 17856-0149 Oxybutynin Chloride
Product NDC 17856-0149
11-digit product format 178560149
Labeler code 17856
Product ID 17856-0149_35cef500-044f-9368-e063-6294a90a9ae5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxybutynin Chloride
Dosage form SYRUP
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 17856-0149-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 17856-0149-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 17856-0149-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 17856-0149-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 17856-0149-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 17856-0149-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 17856-0149-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 17856-0149-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 17856-0149-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17856-0149-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0149-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 17856-0149-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 17856-0149-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 17856-0149-1 bd6a592717d7…303034d00443…
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 2027-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0149-1 Oxybutynin Chloride 5 mL in 1 CUP, UNIT-DOSE SYRUP 5 3 17856-0149-1 Oxybutynin Chloride 72 in 1 BOX, UNIT-DOSE SYRUP 72 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0149 OXYBUTYNIN CHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORP.] 3 Current NDC, Legacy NDC, 2 package rows 20250524_fe4ed76b-0009-455f-be30-47e80fc1afdf.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 Marketing start Marketing end Sample Exclude flag Status 17856-0149-1 17856014901 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0149-1) / 5 mL in 1 CUP, UNIT-DOSE 2020-03-05 0000-00-00 No No Current