Albuterol Tablets, Usp

SPL v4

SPL

SPL Set ID a4709eea-e4a2-46e2-850f-1e6afca01893

Route

ORAL

Published

Effective Date 2022-07-27

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Albuterol (2 mg)

Inactive Ingredients

Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Povidone K30 Silicon Dioxide Sodium Starch Glycolate Type A Potato Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: 10;62 Shape: round Color: white Size: 6 mm Size: 9 mm Score: 2

Marketing Status

ANDA Active Since 2020-10-23

Description

NDC 70771-1511-1 in bottle of 100 tablets Albuterol tablets USP, 2 mg Rx only 100 Tablets NDC 70771-1512-1 in bottle of 100 tablets Albuterol tablets USP, 4 mg Rx only 100 Tablets

Medication Information

Description

NDC 70771-1511-1 in bottle of 100 tablets Albuterol tablets USP, 2 mg Rx only 100 Tablets NDC 70771-1512-1 in bottle of 100 tablets Albuterol tablets USP, 4 mg Rx only 100 Tablets

Package Label.principal Display Panel

NDC 70771-1511-1 in bottle of 100 tablets

Albuterol tablets USP, 2 mg

Rx only

100 Tablets

NDC 70771-1512-1 in bottle of 100 tablets

Albuterol tablets USP, 4 mg

Rx only

100 Tablets

Structured Label Content

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

NDC 70771-1511-1 in bottle of 100 tablets

Albuterol tablets USP, 2 mg

Rx only

100 Tablets

NDC 70771-1512-1 in bottle of 100 tablets

Albuterol tablets USP, 4 mg

Rx only

100 Tablets

Advanced Ingredient Data

[{"name": "ALBUTEROL", "unii": "QF8SVZ843E", "classCode": "ACTIM", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALBUTEROL", "unii": "QF8SVZ843E", "classCode": "ACTIM", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1511-1 in bottle of 100 tablets Albuterol tablets USP, 2 mg Rx only 100 Tablets NDC 70771-1512-1 in bottle of 100 tablets Albuterol tablets USP, 4 mg Rx only 100 Tablets"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:43:57.476759 · Updated: 2026-03-14T22:18:11.806691