Home NDC 0143-3126 Dicyclomine hydrochloride
Product NDC 0143-3126
11-digit product format 001433126
Labeler code 0143
Product ID 0143-3126_008f2526-f7fc-4c9b-939d-04661bcec6be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA040204
Marketing category ANDA
Marketing start 1997-02-28
Marketing end 0000-00-00
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 54 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A040204-001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040204-001 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 · 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 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DICYCLOMINE HYDROCHLORIDE ACTIVE INGREDIENT CQ903KQA31 DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 3 DICYCLOMINE HYDROCHLORIDE ACTIVE INGREDIENT CQ903KQA31 DICYCLOMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] 3 DICYCLOMINE ACTIVE MOIETY 4KV4X8IF6V DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 3 DICYCLOMINE ACTIVE MOIETY 4KV4X8IF6V DICYCLOMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DICYCLOMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] 3 FD&C RED NO. 4 INACTIVE INGREDIENT X3W0AM1JLX DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DICYCLOMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 3 DICYCLOMINE HYDROCHLORIDE ACTIVE INGREDIENT CQ903KQA31 DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.] 1 DICYCLOMINE HYDROCHLORIDE ACTIVE INGREDIENT CQ903KQA31 DICYCLOMINE HYDROCHLORIDE CAPSULE [STAT RX USA] 1 DICYCLOMINE HYDROCHLORIDE ACTIVE INGREDIENT CQ903KQA31 DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 DICYCLOMINE HYDROCHLORIDE ACTIVE INGREDIENT CQ903KQA31 DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 DICYCLOMINE ACTIVE MOIETY 4KV4X8IF6V DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 DICYCLOMINE ACTIVE MOIETY 4KV4X8IF6V DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 DICYCLOMINE ACTIVE MOIETY 4KV4X8IF6V DICYCLOMINE HYDROCHLORIDE CAPSULE [STAT RX USA] 1 DICYCLOMINE ACTIVE MOIETY 4KV4X8IF6V DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.] 1 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD DICYCLOMINE HYDROCHLORIDE CAPSULE [STAT RX USA] 1 FD&C RED NO. 4 INACTIVE INGREDIENT X3W0AM1JLX DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 FD&C RED NO. 4 INACTIVE INGREDIENT X3W0AM1JLX DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 Lactose Monohydrate INACTIVE INGREDIENT EWQ57Q8I5X DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DICYCLOMINE HYDROCHLORIDE CAPSULE [STAT RX USA] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
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 · 3 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 0143-3126-01 00143312601 100 CAPSULE in 1 BOTTLE, PLASTIC (0143-3126-01) 100 capsule 1997-02-28 0000-00-00 No No Current 0143-3126-10 00143312610 1000 CAPSULE in 1 BOTTLE, PLASTIC (0143-3126-10) 1000 capsule 1997-02-28 0000-00-00 No No Current