FDA.reportPublic FDA data

Lansoprazole

Product NDC
70756-807
11-digit product format
707560807
Labeler code
70756
Product ID
70756-807_dab4135b-99b4-bb07-e053-2a95a90aae5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Lifestar Pharma LLC.
Application
ANDA205868
Marketing category
ANDA
Marketing start
2018-06-04
Substance
LANSOPRAZOLE
Active strength
30 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
LANSOPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui311277, 596843

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-807-30Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3014
70756-807-51Lansoprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50014
70756-807-90Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-807-30EA - Each70756-807955c6d29-942c-4f73-8912-cfb61f5d620312018-05-09
70756-807-51EA - Each70756-80717229afc-eedf-44b7-a404-74a9404a7a8912018-05-09
70756-807-90EA - Each70756-8077d8205fb-4ee4-411d-8b38-58710474795712018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-807LANSOPRAZOLE CAPSULE, DELAYED RELEASE [LIFESTAR PHARMA LLC.]14Current NDC, Legacy NDC, 3 package rows20220328_afcc0f14-8b00-41ac-8e62-4094a15b959c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNafcc0f14-8b00-41ac-8e62-4094a15b959c14
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNafcc0f14-8b00-41ac-8e62-4094a15b959c14
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDafcc0f14-8b00-41ac-8e62-4094a15b959c14
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDafcc0f14-8b00-41ac-8e62-4094a15b959c14
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN7286d6a5-611b-4993-ab93-4899d599435d7
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD7286d6a5-611b-4993-ab93-4899d599435d7
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN8f0d3f2f-91d9-467a-a841-540664af80f96
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN9a277b9e-2e13-27c3-e053-2995a90a7ed56
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNce1a4f32-da65-29d3-e053-2995a90a42ee6
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD8f0d3f2f-91d9-467a-a841-540664af80f96
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD9a277b9e-2e13-27c3-e053-2995a90a7ed56
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDce1a4f32-da65-29d3-e053-2995a90a42ee6
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNe5bcfc5b-f5a9-3260-e053-2a95a90ab70e4
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDe5bcfc5b-f5a9-3260-e053-2a95a90ab70e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70756-807-307075608073030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70756-807-30) 2018-06-040000-00-00NoNoCurrent
70756-807-5170756080751500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70756-807-51) 2018-06-040000-00-00NoNoCurrent
70756-807-907075608079090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70756-807-90) 2018-06-040000-00-00NoNoCurrent