FDA.reportPublic FDA data

CEVIMELINE HYDROCHLORIDE

Product NDC
71335-2326
11-digit product format
713352326
Labeler code
71335
Product ID
71335-2326_2fcca18a-cdb5-4a3c-a861-6042764347d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEVIMELINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA216682
Marketing category
ANDA
Marketing start
2023-04-06
Substance
CEVIMELINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
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
A216682-001CEVIMELINE HYDROCHLORIDECEVIMELINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216682-001AB

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
2026-08-01 22:54:322026-06A216682-001CEVIMELINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216682-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CEVIMELINE HYDROCHLORIDECEVIMELINE HYDROCHLORIDEBryant Ranch Prepack75ae16d6-8822-4581-b747-ae894a45cdea2026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216682
application number: ANDA216682
ndc (product): 71335-2326
CEVIMELINE HYDROCHLORIDECEVIMELINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2b429ea7-1c7c-47a4-803c-2546736f5c362026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216682
application number: ANDA216682
CEVIMELINE HYDROCHLORIDECEVIMELINE HYDROCHLORIDEAdvagen Pharma Ltd61dd5ee1-cf89-43ea-ada4-4e4a4d9d133b2025-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216682
application number: ANDA216682

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEVIMELINE HYDROCHLORIDE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P81Q6V85NPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309140Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
75ae16d6-8822-4581-b747-ae894a45cdeaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ee6cfc6-9666-4038-bf74-eee52d7e4a72Product name420250331

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2326-1CEVIMELINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICCAPSULE30101
71335-2326-2CEVIMELINE HYDROCHLORIDE60 in 1 BOTTLE, PLASTICCAPSULE60101
71335-2326-3CEVIMELINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICCAPSULE90101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2326CEVIMELINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 3 package rows20240113_75ae16d6-8822-4581-b747-ae894a45cdea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309140cevimeline HCl 30 MG Oral CapsulePSN75ae16d6-8822-4581-b747-ae894a45cdea101
309140cevimeline hydrochloride 30 MG Oral CapsuleSCD75ae16d6-8822-4581-b747-ae894a45cdea101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2326-17133523260130 CAPSULE in 1 BOTTLE, PLASTIC (71335-2326-1) 30 capsule2024-01-08NoNoCurrent
71335-2326-27133523260260 CAPSULE in 1 BOTTLE, PLASTIC (71335-2326-2) 60 capsule2024-01-08NoNoCurrent
71335-2326-37133523260390 CAPSULE in 1 BOTTLE, PLASTIC (71335-2326-3) 90 capsule2024-01-08NoNoCurrent