Sacubitril And Valsartan Tablets

Sacubitril And Valsartan Tablets
SPL v1
SPL
SPL Set ID 4c871c01-0564-411f-87e2-478aa42503cf
Route
ORAL
Published
Effective Date 2025-07-08
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sacubitrilat (24 mg) Valsartan (26 mg)
Inactive Ingredients
Crospovidone (15 Mpa.s At 5%) Hydroxypropyl Cellulose, Low Substituted Hypromellose 2910 (6 Mpa.s) Microcrystalline Cellulose 101 Microcrystalline Cellulose 102 Polyethylene Glycol 8000 Silicon Dioxide Sodium Stearyl Fumarate Titanium Dioxide Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Aluminum Oxide Fd&c Blue No. 2--aluminum Lake Fd&c Red No. 40 Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Imprint: 73 Shape: oval Color: white Color: brown Color: orange Size: 10 mm Size: 13 mm Size: 15 mm Score: 1
Marketing Status
ANDA Active Since 2025-07-08

Description

NDC 70771-1921-6 Sacubitril and valsartan tablets, 24 mg/26 mg 60 Tablets Rx only NDC 70771-1922-6 Sacubitril and valsartan tablets, 49 mg/51 mg 60 Tablets Rx only NDC 70771-1923-6 Sacubitril and valsartan tablets, 97 mg/103 mg 60 Tablets Rx only


Medication Information

Description

NDC 70771-1921-6 Sacubitril and valsartan tablets, 24 mg/26 mg 60 Tablets Rx only NDC 70771-1922-6 Sacubitril and valsartan tablets, 49 mg/51 mg 60 Tablets Rx only NDC 70771-1923-6 Sacubitril and valsartan tablets, 97 mg/103 mg 60 Tablets Rx only

Package Label.principal Display Panel

NDC 70771-1921-6

Sacubitril and valsartan tablets, 24 mg/26 mg

60 Tablets

Rx only

NDC 70771-1922-6

Sacubitril and valsartan tablets, 49 mg/51 mg

60 Tablets

Rx only

NDC 70771-1923-6

Sacubitril and valsartan tablets, 97 mg/103 mg

60 Tablets

Rx only


Structured Label Content

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

NDC 70771-1921-6

Sacubitril and valsartan tablets, 24 mg/26 mg

60 Tablets

Rx only

NDC 70771-1922-6

Sacubitril and valsartan tablets, 49 mg/51 mg

60 Tablets

Rx only

NDC 70771-1923-6

Sacubitril and valsartan tablets, 97 mg/103 mg

60 Tablets

Rx only


Advanced Ingredient Data


Raw Label Data

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