Dicyclomine Hydrochloride

Product NDC
59651-719
Requested package NDC
59651-719-99
11-digit product format
596510719
Labeler code
59651
Product ID
59651-719_ec746016-eed0-4e37-bb9c-cb430c8a7f07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA040319
Marketing category
ANDA
Marketing start
2023-05-08
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
A040319-001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040319-001AB

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 UTC2026-02A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-073f01610625f2…
2019-09-15 20:21 UTC2019-09A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040319-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB1999-09-07cb3db0bc1861…

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 UTC2026-02A040319-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040319-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040319-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040319-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040319-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040319-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040319-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040319-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040319-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040319-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040319-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040319-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040319-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040319-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040319-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040319-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040319-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040319-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040319-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040319-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040319-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040319-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040319-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040319-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040319-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040319-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040319-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040319-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040319-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040319-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040319-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040319-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040319-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040319-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040319-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040319-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040319-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040319-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040319-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040319-001AB1cb3db0bc1861…

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
ec746016-eed0-4e37-bb9c-cb430c8a7f07Available 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
59651-719-01Dicyclomine Hydrochloride100 in 1 BOTTLECAPSULE1001
59651-719-99Dicyclomine Hydrochloride1000 in 1 BOTTLECAPSULE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-719-01EA - Each59651-7194e1d7469-c680-4242-8f4d-0a820351e55412023-09-05
59651-719-99EA - Each59651-719c832e100-88c9-4b69-8f36-0f42757a045112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-719DICYCLOMINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20230523_ec746016-eed0-4e37-bb9c-cb430c8a7f07.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDECoupler LLC508a7d45-4efd-8532-e063-6294a90a77412026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040319
application number: ANDA040319
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepack21ec88b3-22c7-492b-bfb1-73d3f98525222026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040319
application number: ANDA040319
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.e67ad329-6395-4fa0-a898-f13959034e262025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040319
application number: ANDA040319
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a5864c57-d73c-45c6-8985-7a041c84ccad2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040319
application number: ANDA040319
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.20ef2c05-d0a4-405c-e063-6394a90ae6972024-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040319
application number: ANDA040319
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepack07361f0e-90c7-4531-8d3f-1ec5e7fed40d2024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040319
application number: ANDA040319
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEAurobindo Pharma Limitedec746016-eed0-4e37-bb9c-cb430c8a7f072023-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040319
application number: ANDA040319
ndc (package): 59651-719-99
ndc (product): 59651-719
ndc11 (package): 59651071999

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN07361f0e-90c7-4531-8d3f-1ec5e7fed40d101
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD07361f0e-90c7-4531-8d3f-1ec5e7fed40d101
991061dicyclomine HCl 10 MG Oral CapsulePSN21ec88b3-22c7-492b-bfb1-73d3f9852522100
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD21ec88b3-22c7-492b-bfb1-73d3f9852522100
991061dicyclomine HCl 10 MG Oral CapsulePSN115dbb2f-e8f7-2189-e063-6294a90aacd73
991061dicyclomine HCl 10 MG Oral CapsulePSNa5864c57-d73c-45c6-8985-7a041c84ccad3
991061dicyclomine HCl 10 MG Oral CapsulePSNe67ad329-6395-4fa0-a898-f13959034e263
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD115dbb2f-e8f7-2189-e063-6294a90aacd73
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDa5864c57-d73c-45c6-8985-7a041c84ccad3
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDe67ad329-6395-4fa0-a898-f13959034e263
991061dicyclomine HCl 10 MG Oral CapsulePSN20ef2c05-d0a4-405c-e063-6394a90ae6971
991061dicyclomine HCl 10 MG Oral CapsulePSN508a7d45-4efd-8532-e063-6294a90a77411
991061dicyclomine HCl 10 MG Oral CapsulePSNec746016-eed0-4e37-bb9c-cb430c8a7f071
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD20ef2c05-d0a4-405c-e063-6394a90ae6971
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD508a7d45-4efd-8532-e063-6294a90a77411
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDec746016-eed0-4e37-bb9c-cb430c8a7f071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-719-99596510719991000 CAPSULE in 1 BOTTLE (59651-719-99) 1000 capsule2023-05-08NoNoCurrent