Dicyclomine Hydrochloride

Product NDC
71335-0425
11-digit product format
713350425
Labeler code
71335
Product ID
71335-0425_8bde11c1-3380-437d-beda-1eb263058208
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040230
Marketing category
ANDA
Marketing start
1999-02-26
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 42.

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
A040230-001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040230-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-263f01610625f2…
2019-09-15 20:21 UTC2019-09A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040230-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1999-02-26e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040230-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040230-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040230-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040230-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040230-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040230-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040230-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040230-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040230-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040230-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040230-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040230-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040230-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040230-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040230-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040230-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040230-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040230-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040230-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040230-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040230-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040230-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040230-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040230-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040230-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040230-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040230-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040230-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040230-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040230-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040230-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040230-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040230-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040230-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040230-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040230-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040230-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040230-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040230-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040230-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE20 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
991086Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
34db5a80-f445-41e5-b3c4-4c18abb09c92Available 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
71335-0425-1Dicyclomine Hydrochloride30 in 1 BOTTLETABLET3010
71335-0425-2Dicyclomine Hydrochloride40 in 1 BOTTLETABLET4010
71335-0425-3Dicyclomine Hydrochloride60 in 1 BOTTLETABLET6010
71335-0425-4Dicyclomine Hydrochloride90 in 1 BOTTLETABLET9010
71335-0425-5Dicyclomine Hydrochloride20 in 1 BOTTLETABLET2010
71335-0425-6Dicyclomine Hydrochloride21 in 1 BOTTLETABLET2110
71335-0425-7Dicyclomine Hydrochloride120 in 1 BOTTLETABLET12010
71335-0425-8Dicyclomine Hydrochloride100 in 1 BOTTLETABLET10010
71335-0425-9Dicyclomine Hydrochloride28 in 1 BOTTLETABLET2810

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0425-1EA - Each71335-04256e6bc18a-194e-4dab-b14e-40ffbbf028a612018-03-08
71335-0425-2EA - Each71335-0425fec8e589-6229-4e59-9237-fd80268ab1d512018-03-08
71335-0425-3EA - Each71335-0425a239c964-e4cc-48e4-94c7-fcf1d2b0f77e12018-03-08
71335-0425-4EA - Each71335-0425630bd52a-c02c-4a5a-9709-09de7072d32012018-03-08
71335-0425-5EA - Each71335-0425fa5b3465-8208-43f3-8cbc-ce4b5888410412018-03-08
71335-0425-6EA - Each71335-04253c7c6df1-ae12-47f5-937e-94f039c2b67312018-03-08
71335-0425-7EA - Each71335-04250217747d-3b23-4652-be69-c654e4f11ae912018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0425DICYCLOMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 9 package rows20240828_34db5a80-f445-41e5-b3c4-4c18abb09c92.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDELannett Company, LLCbd2cba10-70ec-4d1f-b46c-53d1de2ee1302026-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040230
application number: ANDA040230
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepack3dc0f4f0-ee38-4f9b-abb6-6395215fe5242026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040230
application number: ANDA040230
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepack34db5a80-f445-41e5-b3c4-4c18abb09c922026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040230
application number: ANDA040230
ndc (product): 71335-0425
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.7ff96d1f-fb87-4244-a697-1d93e10eb7382026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040230
application number: ANDA040230
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEMajor Pharmaceuticals5eee0dff-d157-4534-adfb-c035b7042c072026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040230
application number: ANDA040230
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.6fb9d156-f321-4f7d-b308-2a0e6056fd712026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040230
application number: ANDA040230
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENorthwind Health Company, LLCda82cb46-7b4b-1ef5-e053-2a95a90ad10d2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040230
application number: ANDA040230
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEProficient Rx LP3b7145d7-1ba7-45c1-8202-b8fc575d5a8e2025-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040230
application number: ANDA040230
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEChartwell RX, LLCd628ac1c-404d-45eb-8aab-0e550c95ed4a2024-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040230
application number: ANDA040230
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.82832a91-d16c-3a63-e053-2a91aa0a3ffb2024-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040230
application number: ANDA040230
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEAmerican Health Packaging833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe82024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040230
application number: ANDA040230
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEA-S Medication Solutionsb3c9dc85-2c6c-44f0-9c98-02673af934cb2024-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040230
application number: ANDA040230
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCda2c43f8-1c3a-447f-8994-f9899fb5e1412018-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040230
application number: ANDA040230

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN34db5a80-f445-41e5-b3c4-4c18abb09c9210
991086dicyclomine hydrochloride 20 MG Oral TabletSCD34db5a80-f445-41e5-b3c4-4c18abb09c9210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0425-17133504250130 TABLET in 1 BOTTLE (71335-0425-1) 30 tablet2018-02-220000-00-00NoNoCurrent
71335-0425-27133504250240 TABLET in 1 BOTTLE (71335-0425-2) 40 tablet2021-12-270000-00-00NoNoCurrent
71335-0425-37133504250360 TABLET in 1 BOTTLE (71335-0425-3) 60 tablet2020-11-120000-00-00NoNoCurrent
71335-0425-47133504250490 TABLET in 1 BOTTLE (71335-0425-4) 90 tablet2020-03-260000-00-00NoNoCurrent
71335-0425-57133504250520 TABLET in 1 BOTTLE (71335-0425-5) 20 tablet2018-05-040000-00-00NoNoCurrent
71335-0425-67133504250621 TABLET in 1 BOTTLE (71335-0425-6) 21 tablet2021-12-270000-00-00NoNoCurrent
71335-0425-771335042507120 TABLET in 1 BOTTLE (71335-0425-7) 120 tablet2021-12-270000-00-00NoNoCurrent
71335-0425-871335042508100 TABLET in 1 BOTTLE (71335-0425-8) 100 tablet2021-12-270000-00-00NoNoCurrent
71335-0425-97133504250928 TABLET in 1 BOTTLE (71335-0425-9) 28 tablet2020-06-010000-00-00NoNoCurrent