Home NDC 63629-2179-1 dicyclomine hydrochloride
Product NDC 63629-2179
Requested package NDC 63629-2179-1
11-digit product format 636292179
Labeler code 63629
Product ID 63629-2179_22154b09-793e-49c7-a7e7-e3949261a4db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dicyclomine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA040169
Marketing category ANDA
Marketing start 2005-06-23
Marketing end 0000-00-00
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 10 mg/5mL
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A040169-001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040169-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL RS 2005-03-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL RS 2005-03-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL RS 2005-03-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL RS 2005-03-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-2179-1 63629217901 473 mL in 1 BOTTLE, PLASTIC (63629-2179-1) 473 ml 2021-03-12 0000-00-00 No No Current