FDA.reportPublic FDA data

cevimeline hydrochloride

Product NDC
40032-999
11-digit product format
400320999
Labeler code
40032
Product ID
40032-999_c42fae45-bbcf-40b6-911d-ebe3893f10ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cevimeline hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA204746
Marketing category
ANDA
Marketing start
2016-12-30
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
2026-12-31
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
A204746-001CEVIMELINE HYDROCHLORIDECEVIMELINE HYDROCHLORIDE30MGCAPSULE / ORALAB2016-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204746-001AB

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 22:54:322026-06A204746-001CEVIMELINE HYDROCHLORIDE30MGCAPSULE / ORALAB2016-12-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204746-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cevimeline hydrochlorideCEVIMELINE HYDROCHLORIDELupin Pharmaceuticals,Inc.0fbcf1a7-5b8b-42fb-b764-4b529e7d1a992024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204746
application number: ANDA204746
cevimeline hydrochlorideCEVIMELINE HYDROCHLORIDENovel Laboratories, Inc.d7432a48-1142-431e-997f-8419dc7248242016-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204746
application number: ANDA204746
ndc (product): 40032-999

Additional Listing Data#

Finished product
Yes
Brand name base
cevimeline hydrochloride
Listing expiration
2026-12-31

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
d7432a48-1142-431e-997f-8419dc724824Available 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
40032-999-01cevimeline hydrochloride100 in 1 BOTTLECAPSULE1001
40032-999-03cevimeline hydrochloride30 in 1 BOTTLECAPSULE301
40032-999-05cevimeline hydrochloride500 in 1 BOTTLECAPSULE5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-999CEVIMELINE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.]1Current NDC, Legacy NDC, 3 package rows20171207_d7432a48-1142-431e-997f-8419dc724824.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309140cevimeline HCl 30 MG Oral CapsulePSNd7432a48-1142-431e-997f-8419dc7248241
309140cevimeline hydrochloride 30 MG Oral CapsuleSCDd7432a48-1142-431e-997f-8419dc7248241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-999-0140032099901100 CAPSULE in 1 BOTTLE (40032-999-01) 100 capsule2016-12-300000-00-00NoNoCurrent
40032-999-034003209990330 CAPSULE in 1 BOTTLE (40032-999-03) 30 capsule2016-12-300000-00-00NoNoCurrent
40032-999-0540032099905500 CAPSULE in 1 BOTTLE (40032-999-05) 500 capsule2016-12-300000-00-00NoNoCurrent