Home NDC 43063-045 Dicyclomine Hydrochloride
Product NDC 43063-045
11-digit product format 430630045
Labeler code 43063
Product ID 43063-045_2b247a51-9783-e240-e063-6294a90a8907
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA085223
Marketing category ANDA
Marketing start 1986-07-30
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 20 mg/1
Pharmacologic classes Anticholinergic [EPC], Cholinergic 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 A085223-001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A085223-001 AB
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 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1986-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1986-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1986-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1986-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A085223-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1986-07-30 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 Dicyclomine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICYCLOMINE HYDROCHLORIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination CQ903KQA31 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 991086 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 43063-045-04 Dicyclomine Hydrochloride 4 in 1 BOTTLE, PLASTIC TABLET 4 32 43063-045-06 Dicyclomine Hydrochloride 6 in 1 BOTTLE, PLASTIC TABLET 6 32 43063-045-20 Dicyclomine Hydrochloride 20 in 1 BOTTLE, PLASTIC TABLET 20 32 43063-045-30 Dicyclomine Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET 30 32 43063-045-60 Dicyclomine Hydrochloride 60 in 1 BOTTLE, PLASTIC TABLET 60 32
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DICYCLOMINE HYDROCHLORIDE ACTIVE INGREDIENT CQ903KQA31 DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 DICYCLOMINE ACTIVE MOIETY 4KV4X8IF6V DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-045 DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 32 Current NDC, Legacy NDC, 5 package rows 20250109_da0e1f63-cb90-4c2a-908f-7d81e672be10.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dicyclomine Hydrochloride DICYCLOMINE HYDROCHLORIDE Northwind Health Company, LLC c195b8ea-c1bf-453f-e053-2a95a90a2121 2026-01-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 085223 application number: ANDA085223 Dicyclomine Hydrochloride DICYCLOMINE HYDROCHLORIDE PD-Rx Pharmaceuticals, Inc. da0e1f63-cb90-4c2a-908f-7d81e672be10 2025-01-07 Warnings, Adverse reactions Exact identifier application applno (ANDA): 085223 application number: ANDA085223 ndc (product): 43063-045 Dicyclomine Hydrochloride DICYCLOMINE HYDROCHLORIDE NuCare Pharmaceuticals, Inc. 517646d8-366e-5cf2-e054-00144ff88e88 2024-07-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 085223 application number: ANDA085223 Dicyclomine Hydrochloride DICYCLOMINE HYDROCHLORIDE Actavis Pharma, Inc. a5937c7b-cdfc-46e6-a0fa-541b24f91d47 2024-04-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 085223 application number: ANDA085223 Dicyclomine Hydrochloride DICYCLOMINE HYDROCHLORIDE Proficient Rx LP bd8b7fcd-04f4-4d1c-aa27-743aaf4c2876 2022-03-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 085223 application number: ANDA085223
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 43063-045-04 43063004504 4 TABLET in 1 BOTTLE, PLASTIC (43063-045-04) 4 tablet 2008-12-22 0000-00-00 No No Current 43063-045-06 43063004506 6 TABLET in 1 BOTTLE, PLASTIC (43063-045-06) 6 tablet 2013-09-17 0000-00-00 No No Current 43063-045-20 43063004520 20 TABLET in 1 BOTTLE, PLASTIC (43063-045-20) 20 tablet 2013-09-17 0000-00-00 No No Current 43063-045-30 43063004530 30 TABLET in 1 BOTTLE, PLASTIC (43063-045-30) 30 tablet 2013-08-07 0000-00-00 No No Current 43063-045-60 43063004560 60 TABLET in 1 BOTTLE, PLASTIC (43063-045-60) 60 tablet 2014-04-14 0000-00-00 No No Current