Dicyclomine Hydrochloride

Product NDC
0591-0794
Requested package NDC
0591-0794-00
11-digit product format
005910794
Labeler code
0591
Product ID
0591-0794_cdc9e5f4-36d9-40dc-894f-2d8682e4a61b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage0591-07940591-0794-00UNFINISHEDActive or certified unfinished drug listing2026-08-12

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
991061Internal RxNorm lookup
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
a5937c7b-cdfc-46e6-a0fa-541b24f91d47Available 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
0591-0794-01Dicyclomine Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE10020
0591-0794-10Dicyclomine Hydrochloride1000 in 1 BOTTLE, PLASTICCAPSULE100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0794-01EA - Each0591-0794dd7230b2-c164-45dc-bb60-2544cc48c0c012012-07-24
0591-0794-10EA - Each0591-079408447d5e-518d-45bd-a330-51ebf8c5c74b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]15
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]15
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]15
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]15
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]15
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]15
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]15
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]15
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]15
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]15
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDICYCLOMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDICYCLOMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDICYCLOMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WODICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0794DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]20Current NDC, Legacy NDC, 2 package rows20241116_a5937c7b-cdfc-46e6-a0fa-541b24f91d47.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
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
ndc (product): 0591-0794
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 CapsulePSNb3b8ee01-ec7c-4b17-a237-59ba45cdf3f9101
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDb3b8ee01-ec7c-4b17-a237-59ba45cdf3f9101
991061dicyclomine HCl 10 MG Oral CapsulePSNb3d591ad-4eb7-4cdf-93b2-62cd479e921b32
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDb3d591ad-4eb7-4cdf-93b2-62cd479e921b32
991061dicyclomine HCl 10 MG Oral CapsulePSN820d2d23-34ce-439a-8130-49d9a93c028330
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD820d2d23-34ce-439a-8130-49d9a93c028330
991061dicyclomine HCl 10 MG Oral CapsulePSN8b242ad1-0438-42ed-931b-8f85ea9bc66028
991086dicyclomine HCl 20 MG Oral TabletPSN8b242ad1-0438-42ed-931b-8f85ea9bc66028
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD8b242ad1-0438-42ed-931b-8f85ea9bc66028
991086dicyclomine hydrochloride 20 MG Oral TabletSCD8b242ad1-0438-42ed-931b-8f85ea9bc66028
991061dicyclomine HCl 10 MG Oral CapsulePSN87cd2a04-54d6-4022-b365-646692a42f5626
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD87cd2a04-54d6-4022-b365-646692a42f5626
991061dicyclomine HCl 10 MG Oral CapsulePSN8c29140b-e181-4807-870f-28e315c6d4c424
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD8c29140b-e181-4807-870f-28e315c6d4c424
991061dicyclomine HCl 10 MG Oral CapsulePSNa5937c7b-cdfc-46e6-a0fa-541b24f91d4720
991086dicyclomine HCl 20 MG Oral TabletPSNa5937c7b-cdfc-46e6-a0fa-541b24f91d4720
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDa5937c7b-cdfc-46e6-a0fa-541b24f91d4720
991086dicyclomine hydrochloride 20 MG Oral TabletSCDa5937c7b-cdfc-46e6-a0fa-541b24f91d4720
991061dicyclomine HCl 10 MG Oral CapsulePSN7cbefee1-1b23-4e9b-8527-ec357a9dbcb68
991086dicyclomine HCl 20 MG Oral TabletPSN7cbefee1-1b23-4e9b-8527-ec357a9dbcb68
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD7cbefee1-1b23-4e9b-8527-ec357a9dbcb68
991086dicyclomine hydrochloride 20 MG Oral TabletSCD7cbefee1-1b23-4e9b-8527-ec357a9dbcb68
991061dicyclomine HCl 10 MG Oral CapsulePSN40e21575-320f-2ac6-e054-00144ff88e885
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD40e21575-320f-2ac6-e054-00144ff88e885
991061dicyclomine HCl 10 MG Oral CapsulePSNf5dd6ecc-440d-6c47-e053-2a95a90a92d33
991061dicyclomine HCl 10 MG Oral CapsulePSN1d257aa6-9963-4732-93b0-797b06c994ce3
991061dicyclomine HCl 10 MG Oral CapsulePSN2131a563-f739-4aee-a3ea-cfdc399799ab3
991061dicyclomine HCl 10 MG Oral CapsulePSN51742add-363d-3f9d-e054-00144ff8d46c3
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDf5dd6ecc-440d-6c47-e053-2a95a90a92d33
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD1d257aa6-9963-4732-93b0-797b06c994ce3
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD51742add-363d-3f9d-e054-00144ff8d46c3
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD2131a563-f739-4aee-a3ea-cfdc399799ab3
991061dicyclomine HCl 10 MG Oral CapsulePSN346bbb6a-3499-4e90-af22-95f1cd0c04172
991061dicyclomine HCl 10 MG Oral CapsulePSNbaae1478-e5e8-44d1-bb8a-9f456861491f2
991061dicyclomine HCl 10 MG Oral CapsulePSNd9bb7ff1-8dbc-d191-e053-2995a90a13db2
991061dicyclomine HCl 10 MG Oral CapsulePSNdeb3a0bd-220f-4956-9219-bde9a6f0df172
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD346bbb6a-3499-4e90-af22-95f1cd0c04172
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDdeb3a0bd-220f-4956-9219-bde9a6f0df172
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDd9bb7ff1-8dbc-d191-e053-2995a90a13db2
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDbaae1478-e5e8-44d1-bb8a-9f456861491f2
991061dicyclomine HCl 10 MG Oral CapsulePSN5cc4daa2-f108-4672-9dd8-06c3785bed281
991061dicyclomine HCl 10 MG Oral CapsulePSNf325dd3d-8ebe-4aa3-8c45-43438c75defe1
991061dicyclomine HCl 10 MG Oral CapsulePSN1c062a81-e36a-4d71-e063-6294a90abfd21
991061dicyclomine HCl 10 MG Oral CapsulePSN59ca0395-599b-0d7e-e053-2a91aa0a2c911
991086dicyclomine HCl 20 MG Oral TabletPSN59ca0395-599b-0d7e-e053-2a91aa0a2c911
991086dicyclomine HCl 20 MG Oral TabletPSNf325dd3d-8ebe-4aa3-8c45-43438c75defe1
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD59ca0395-599b-0d7e-e053-2a91aa0a2c911
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDf325dd3d-8ebe-4aa3-8c45-43438c75defe1
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD5cc4daa2-f108-4672-9dd8-06c3785bed281
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD1c062a81-e36a-4d71-e063-6294a90abfd21
991086dicyclomine hydrochloride 20 MG Oral TabletSCD59ca0395-599b-0d7e-e053-2a91aa0a2c911
991086dicyclomine hydrochloride 20 MG Oral TabletSCDf325dd3d-8ebe-4aa3-8c45-43438c75defe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
0591-0794-000059107940042017 CAPSULE in 1 BOX (0591-0794-00)42017 capsule24-JUN-24Current