Cevimeline Hydrochloride

Product NDC
0054-0334
11-digit product format
000540334
Labeler code
0054
Product ID
0054-0334_3cca3720-dca8-40cf-8de7-8f3444125ece
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cevimeline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA091591
Marketing category
ANDA
Marketing start
2013-07-08
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
A091591-001CEVIMELINE HYDROCHLORIDECEVIMELINE HYDROCHLORIDE30MGCAPSULE / ORALAB2013-07-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091591-001AB

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 22:54:322026-06A091591-001CEVIMELINE HYDROCHLORIDE30MGCAPSULE / ORALAB2013-07-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091591-001AB1a50c72e98297…

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 HYDROCHLORIDEBryant Ranch Prepackfe30c870-a060-4a5b-ae61-6a99338544192024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091591
application number: ANDA091591
Cevimeline HydrochlorideCEVIMELINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.1167360c-7e0f-4619-9d1a-ad4ee56cab712024-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091591
application number: ANDA091591
ndc (product): 0054-0334

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
1167360c-7e0f-4619-9d1a-ad4ee56cab71Available 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
0054-0334-25Cevimeline Hydrochloride100 in 1 BOTTLECAPSULE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0334-25EA - Each0054-0334a4459332-d9f2-4247-918f-5c0d70569a2a12013-08-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0334CEVIMELINE HYDROCHLORIDE CAPSULE [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 1 package rows20240913_1167360c-7e0f-4619-9d1a-ad4ee56cab71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309140cevimeline HCl 30 MG Oral CapsulePSNfe30c870-a060-4a5b-ae61-6a9933854419101
309140cevimeline hydrochloride 30 MG Oral CapsuleSCDfe30c870-a060-4a5b-ae61-6a9933854419101
309140cevimeline HCl 30 MG Oral CapsulePSN1167360c-7e0f-4619-9d1a-ad4ee56cab717
309140cevimeline hydrochloride 30 MG Oral CapsuleSCD1167360c-7e0f-4619-9d1a-ad4ee56cab717

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0334-2500054033425100 CAPSULE in 1 BOTTLE (0054-0334-25) 100 capsule2013-07-080000-00-00NoNoCurrent