FDA.reportPublic FDA data

NDC 43598-901-11 - ERTAPENEM SODIUM

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
43598-901
Requested NDC
43598-901-11
Package NDCs from labels
43598-901-11, 43598-901-58
Manufacturer
Dr.Reddys Laboratories Inc., | Gland Pharma Limited
Effective date
2021-04-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ERTAPENEM SODIUM - Dr.Reddys Laboratories Inc., | Gland Pharma LimitedDr.Reddys Laboratories Inc., | Gland Pharma Limited2021-04-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-901-11ERTAPENEM SODIUM1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,14
43598-901-58ERTAPENEM SODIUM10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-901ERTAPENEM SODIUM (ERTAPENEM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR.REDDYS LABORATORIES INC.,]4Current NDC, Legacy NDC, 2 package rows20240627_32d9f095-ca39-7e22-6264-b54f2daaee57.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-901-11EA - Each43598-901d1b9e0f8-1a1d-463b-9e6b-5f1f77f67e0312021-05-05
43598-901-58EA - Each43598-90162d1758d-889b-41ca-bba1-f59be9a80b4612021-05-05

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 12 · 222 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ERTAPENEMERTAPENEM SODIUMENDO USA, Inc.657855f2-7c92-4aa8-9c3d-51d08e56a09a2026-03-02Warnings, Adverse reactionsExact identifier
rxcui: 1734683
unii: 2T90KE67L0
Sodium Bicarbonate 5 grSODIUM BICARBONATETWIN MED LLC12cad432-99db-4a9b-8619-82794e29409e2026-03-01WarningsExact identifier
unii: 8MDF5V39QO
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEAmneal Pharmaceuticals Private Limitedba92f45a-0187-4709-aa70-462b8dae09e92026-02-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
INVANZERTAPENEM SODIUMMerck Sharp & Dohme LLC33f3b99b-fa82-42e0-26bf-f49891ae3d222026-02-04Warnings, Adverse reactionsExact identifier
rxcui: 1734683
unii: 2T90KE67L0
ADRIAN BICARBONATO SODIUM BICARBONATE USP-4 oz, 8 oz and 16 ozSODIUM BICARBONATEEvi Labs4979a339-4ad4-9cdd-e063-6394a90a0acc2026-01-28WarningsExact identifier
unii: 8MDF5V39QO
Equate Comfort Flow Sinus washSINUS WASHWALMART INC9e911eef-ca99-9902-e053-2a95a90aab0e2026-01-19WarningsExact identifier
unii: 8MDF5V39QO
D-D SUDIUM BICARBONATE U.S.P. BICARBONATO DE SODA PUROSODIUM BICARBONATEEvi Labs485f9eb1-6535-c47c-e063-6394a90ae32c2026-01-14WarningsExact identifier
unii: 8MDF5V39QO
ErtapenemERTAPENEM SODIUMSagent Pharmaceuticals124775ed-1271-4581-be52-b7a08c91283d2026-01-09Warnings, Adverse reactionsExact identifier
rxcui: 1734683
unii: 2T90KE67L0
Sanar Baking Soda 8oz 100% pureSODIUM BICARBONATEEvi Labs47e7f801-3176-288c-e063-6394a90abef42026-01-08WarningsExact identifier
unii: 8MDF5V39QO
DR. SANA BICARBONATO DE SODIO 4 Fl oz and 6 FlozSODIUM BICARBONATEEvi Labs47330d09-7db1-254d-e063-6294a90ae7de2026-01-07WarningsExact identifier
unii: 8MDF5V39QO
DE LA CRUZ SODIUM BICARBONATE ANTACIDSODIUM BICARBONATEDLC Laboratories, Inc.fc469943-9749-45ee-93f7-90fdbcdc72152026-01-07WarningsExact identifier
unii: 8MDF5V39QO
De La Cruz DesempachoSODIUM BICARBONATEDLC LABORATORIES, INC.741e105a-3ed2-4fc7-ab06-273e515a2d162026-01-07WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate 10 grSODIUM BICARBONATEGRAXCELL PHARMACEUTICAL, LLC897dbb09-fb47-4e03-8cae-bf76d48a7a032025-12-25WarningsExact identifier
unii: 8MDF5V39QO
Zegerid OTCOMEPRAZOLE, SODIUM BICARBONATERiley Consumer Care LLC1d764fc5-8eae-4fc9-a2e9-3f1954a3ac052025-12-24WarningsExact identifier
unii: 8MDF5V39QO
ERTAPENEM SODIUMERTAPENEMNorthStar RxLLC2398d418-6efc-b4d2-3265-936001df9b8b2025-12-24Warnings, Adverse reactionsExact identifier
application number: ANDA212040
rxcui: 1734683
unii: 2T90KE67L0
SODIUM BICARBONATESODIUM BICARBONATEProPharma Distribution3867f743-c2cf-a646-e063-6394a90a82e12025-12-18Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
After Bite AdvancedSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands223d1de8-7940-bbdc-e063-6294a90a51d82025-12-18WarningsExact identifier
unii: 8MDF5V39QO
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.beb842fa-2373-4f21-9631-ef20ee1245842025-12-10WarningsExact identifier
unii: 8MDF5V39QO
All natural Saline Packets CareOneSODIUM BICARBONATE, SODIUM CHLORIDEFOODHOLD U.S.A.e32f105d-65cd-8095-e053-2995a90a9b6b2025-12-10WarningsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.