Dicyclomine Hydrochloride

Product NDC
43063-629
Requested package NDC
43063-629-28
11-digit product format
430630629
Labeler code
43063
Product ID
43063-629_2cefb3a8-53f9-e570-e063-6394a90a0aba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA085082
Marketing category
ANDA
Marketing start
1986-06-19
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A085082-001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A085082-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-193f01610625f2…
2019-09-15 20:21 UTC2019-09A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085082-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1986-06-19cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A085082-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085082-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A085082-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085082-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085082-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085082-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085082-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085082-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085082-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085082-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085082-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085082-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085082-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085082-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085082-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085082-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085082-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085082-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085082-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085082-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085082-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A085082-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085082-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085082-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085082-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A085082-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A085082-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085082-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085082-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085082-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085082-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085082-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085082-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085082-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A085082-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A085082-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085082-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A085082-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085082-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085082-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CQ903KQA31Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
991061Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
87cd2a04-54d6-4022-b365-646692a42f56Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f755a917-03bc-45af-a1e3-50286868bfdbProduct name920250303
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-629-28Dicyclomine Hydrochloride28 in 1 BOTTLE, PLASTICCAPSULE2826

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-629DICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]26Current NDC, Legacy NDC, 1 package rows20250131_87cd2a04-54d6-4022-b365-646692a42f56.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENorthwind Health Company, LLCd9bb7ff1-8dbc-d191-e053-2995a90a13db2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085082
application number: ANDA085082
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEQPharma, Inc.f5dd6ecc-440d-6c47-e053-2a95a90a92d32025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085082
application number: ANDA085082
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.87cd2a04-54d6-4022-b365-646692a42f562025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085082
application number: ANDA085082
ndc (package): 43063-629-28
ndc (product): 43063-629
ndc11 (package): 43063062928
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.8c29140b-e181-4807-870f-28e315c6d4c42025-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085082
application number: ANDA085082
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b3d591ad-4eb7-4cdf-93b2-62cd479e921b2025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085082
application number: ANDA085082
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEQuality Care Products, LLC1d257aa6-9963-4732-93b0-797b06c994ce2024-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085082
application number: ANDA085082
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.40e21575-320f-2ac6-e054-00144ff88e882024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085082
application number: ANDA085082
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.51742add-363d-3f9d-e054-00144ff8d46c2024-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085082
application number: ANDA085082
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEActavis Pharma, Inc.a5937c7b-cdfc-46e6-a0fa-541b24f91d472024-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085082
application number: ANDA085082
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepackb3b8ee01-ec7c-4b17-a237-59ba45cdf3f92023-10-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085082
application number: ANDA085082
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEProficient Rx LP346bbb6a-3499-4e90-af22-95f1cd0c04172023-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085082
application number: ANDA085082

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN87cd2a04-54d6-4022-b365-646692a42f5626
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD87cd2a04-54d6-4022-b365-646692a42f5626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-629-284306306292828 CAPSULE in 1 BOTTLE, PLASTIC (43063-629-28) 28 capsule2015-10-140000-00-00NoNoCurrent