Lansoprazole Delayed-release Orally Disintegrating Tablets

Lansoprazole Delayed-release Orally Disintegrating Tablets
SPL v6
SPL
SPL Set ID 76ffd38e-bea8-45a0-b6bd-82f0043ce64d
Route
ORAL
Published
Effective Date 2023-09-27
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lansoprazole (15 mg)
Inactive Ingredients
Anhydrous Citric Acid Aspartame Cellulose, Microcrystalline Crospovidone (15 Mpa.s At 5%) Ferric Oxide Red Glyceryl Monostearate Hydrochloric Acid Hypromelloses Magnesium Carbonate Magnesium Stearate Mannitol Methacrylic Acid And Ethyl Acrylate Copolymer Polyacrylic Acid (250000 Mw) Polyethylene Glycol, Unspecified Polysorbate 80 Silicon Dioxide Sodium Hydroxide Sodium Starch Glycolate Type A Potato Starch, Corn Strawberry Talc Triethyl Citrate Xanthan Gum

Identifiers & Packaging

Pill Appearance
Imprint: 772 Shape: round Color: white Size: 10 mm Size: 13 mm Score: 1
Marketing Status
ANDA Active Since 2018-11-30

Description

NDC 70771-1132-4 Lansoprazole Delayed-release Orally Disintegrating Tablets, 15 mg R x only 100 Tablets (10 x 10 Unit Dose) NDC 70771-1133-4 Lansoprazole Delayed-release Orally Disintegrating Tablets, 30 mg R x only 100 Tablets (10 x 10 Unit Dose)


Medication Information

Description

NDC 70771-1132-4 Lansoprazole Delayed-release Orally Disintegrating Tablets, 15 mg R x only 100 Tablets (10 x 10 Unit Dose) NDC 70771-1133-4 Lansoprazole Delayed-release Orally Disintegrating Tablets, 30 mg R x only 100 Tablets (10 x 10 Unit Dose)

Package Label.principal Display Panel

NDC 70771-1132-4

Lansoprazole Delayed-release Orally Disintegrating Tablets, 15 mg

Rx only

100 Tablets (10 x 10 Unit Dose)

NDC 70771-1133-4

Lansoprazole Delayed-release Orally Disintegrating Tablets, 30 mg

Rx only

100 Tablets (10 x 10 Unit Dose)


Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 70771-1132-4

Lansoprazole Delayed-release Orally Disintegrating Tablets, 15 mg

Rx only

100 Tablets (10 x 10 Unit Dose)

NDC 70771-1133-4

Lansoprazole Delayed-release Orally Disintegrating Tablets, 30 mg

Rx only

100 Tablets (10 x 10 Unit Dose)


Advanced Ingredient Data


Raw Label Data

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