Lansoprazole

Product NDC
37808-934
11-digit product format
378080934
Labeler code
37808
Product ID
37808-934_7c2cebea-4afd-cda9-898b-5e94735a2468
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
H E B
Application
ANDA202194
Marketing category
ANDA
Marketing start
2022-04-12
Substance
LANSOPRAZOLE
Active strength
15 mg/1
Pharmacologic classes
Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui596843

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-934LANSOPRAZOLE CAPSULE, DELAYED RELEASE [H E B]2Current NDC20241203_9e15401b-6cea-4687-8c34-4412734caaac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN9e15401b-6cea-4687-8c34-4412734caaac3
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD9e15401b-6cea-4687-8c34-4412734caaac3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37808-934-14378080934141 BOTTLE in 1 CARTON (37808-934-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2024-07-31NoNoCurrent
37808-934-42378080934423 BOTTLE in 1 CARTON (37808-934-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2024-07-31NoNoCurrent