FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
68071-3255
Requested package NDC
68071-3255-5
11-digit product format
680713255
Labeler code
68071
Product ID
68071-3255_1cc31537-db23-8244-e063-6394a90a3797
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare 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

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-325568071-3255-5IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-325568071-3255-5IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-325568071-3255-5IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
A085223-001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A085223-001AB

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 06:07:402026-07A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1986-07-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1986-07-303f01610625f2…
2019-09-15 20:21 UTC2019-09A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1986-07-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1986-07-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30e64feba35796…

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 06:07:402026-07A085223-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A085223-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085223-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A085223-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085223-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085223-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085223-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085223-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085223-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085223-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085223-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085223-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085223-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085223-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085223-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085223-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085223-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085223-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085223-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085223-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085223-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085223-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A085223-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085223-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085223-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085223-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A085223-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A085223-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085223-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085223-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085223-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085223-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085223-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085223-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085223-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A085223-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A085223-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085223-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A085223-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085223-001AB1e64feba35796…

Additional Listing Data#

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

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
517646d8-366e-5cf2-e054-00144ff88e88Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-3255-12024-07-08These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-22024-07-08These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-32024-07-08These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-52024-07-08These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-62024-07-08These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-82024-07-08These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-92024-07-08These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-12023-01-30These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-22023-01-30These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-32023-01-30These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-52023-01-30These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-62023-01-30These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-82023-01-30These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-92023-01-30These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-12021-02-10These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-22021-02-10These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-32021-02-10These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-52021-02-10These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-62021-02-10These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-82021-02-10These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-92021-02-10These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-12021-01-29These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-22021-01-29These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-32021-01-29These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-52021-01-29These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-62021-01-29These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-82021-01-29These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950
68071-3255-92021-01-29These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3255-1Dicyclomine Hydrochloride10 in 1 BOTTLETABLET105
68071-3255-2Dicyclomine Hydrochloride20 in 1 BOTTLETABLET205
68071-3255-3Dicyclomine Hydrochloride30 in 1 BOTTLETABLET305
68071-3255-5Dicyclomine Hydrochloride15 in 1 BOTTLETABLET155
68071-3255-6Dicyclomine Hydrochloride60 in 1 BOTTLETABLET605
68071-3255-8Dicyclomine Hydrochloride28 in 1 BOTTLETABLET285
68071-3255-9Dicyclomine Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3255DICYCLOMINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 7 package rows20240709_517646d8-366e-5cf2-e054-00144ff88e88.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENorthwind Health Company, LLCc195b8ea-c1bf-453f-e053-2a95a90a21212026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085223
application number: ANDA085223
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.da0e1f63-cb90-4c2a-908f-7d81e672be102025-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085223
application number: ANDA085223
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.517646d8-366e-5cf2-e054-00144ff88e882024-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085223
application number: ANDA085223
ndc (package): 68071-3255-5
ndc (product): 68071-3255
ndc11 (package): 68071325505
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEActavis Pharma, Inc.a5937c7b-cdfc-46e6-a0fa-541b24f91d472024-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085223
application number: ANDA085223
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEProficient Rx LPbd8b7fcd-04f4-4d1c-aa27-743aaf4c28762022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085223
application number: ANDA085223

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN517646d8-366e-5cf2-e054-00144ff88e885
991086dicyclomine hydrochloride 20 MG Oral TabletSCD517646d8-366e-5cf2-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3255-56807132550515 TABLET in 1 BOTTLE (68071-3255-5) 15 tablet2017-06-080000-00-00NoNoCurrent