FDA.reportPublic FDA data

DICYCLOMINE HYDROCHLORIDE

Product NDC
16571-260
Requested package NDC
16571-260-01
11-digit product format
165710260
Labeler code
16571
Product ID
16571-260_239ecf22-4237-4f27-b17c-6fddabcc9d9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICYCLOMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA219242
Marketing category
ANDA
Marketing start
2025-06-23
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A219242-001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB2025-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219242-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A219242-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB2025-06-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219242-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB2025-06-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A219242-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB2025-06-236a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219242-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALAB2025-06-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219242-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219242-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219242-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219242-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
DICYCLOMINE HYDROCHLORIDE
Listing expiration
2027-12-31

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
029baf6d-4e85-48fd-9efc-158fe0f629bbAvailable 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
16571-260-01DICYCLOMINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE1004
16571-260-10DICYCLOMINE HYDROCHLORIDE1000 in 1 BOTTLECAPSULE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-260-01EA - Each16571-260b3e7de44-097b-46a8-8249-f8fb0971ae3f12026-01-08
16571-260-10EA - Each16571-2601cd8c97d-e476-4229-9181-c1044153d72712026-01-08

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDERising Pharma Holdings, Inc.029baf6d-4e85-48fd-9efc-158fe0f629bb2026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219242
application number: ANDA219242
ndc (package): 16571-260-01
ndc (product): 16571-260
ndc11 (package): 16571026001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN029baf6d-4e85-48fd-9efc-158fe0f629bb4
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD029baf6d-4e85-48fd-9efc-158fe0f629bb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-260-0116571026001100 CAPSULE in 1 BOTTLE (16571-260-01) 100 capsule2025-06-23NoNoCurrent