Home NDC 70518-3865 Insulin Aspart
Product NDC 70518-3865
11-digit product format 705183865
Labeler code 70518
Product ID 70518-3865_485a3f8d-de3a-d94f-e063-6294a90ac25f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name insulin aspart
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler REMEDYREPACK INC.
Application BLA020986
Marketing category BLA
Marketing start 2023-09-18
Substance INSULIN ASPART
Active strength 100 [iU]/mL
Pharmacologic classes Insulin Analog [EPC], Insulin [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Insulin Aspart
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INSULIN ASPART 100 [iU]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D933668QVX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1653202 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-3865-0 Insulin Aspart 5 in 1 CARTON INJECTION, SOLUTION 5 5 70518-3865-0 Insulin Aspart 3 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 3 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-3865 INSULIN ASPART INJECTION, SOLUTION [REMEDYREPACK INC.] 2 Current NDC, 2 package rows 20240403_b3d77cb0-cd47-441f-8f54-5329c655da9c.zip
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 1 of 1 · 7 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Insulin Aspart INSULIN ASPART REMEDYREPACK INC. b3d77cb0-cd47-441f-8f54-5329c655da9c 2026-01-14 Warnings, Adverse reactions Exact identifier application number: BLA020986 ndc (product): 70518-3865 Insulin Aspart INSULIN ASPART A-S Medication Solutions c3e4c46e-5211-4f05-b7ab-1e9ad270876b 2024-09-11 Warnings, Adverse reactions Exact identifier application number: BLA020986 Insulin Aspart INSULIN ASPART A-S Medication Solutions bfd2b192-35e5-4773-ab73-802565b2ad78 2024-03-14 Warnings, Adverse reactions Exact identifier application number: BLA020986 NOVOLOG INSULIN ASPART A-S Medication Solutions 13891e5a-e57a-46e8-911c-2f680352b52b 2023-12-15 Warnings, Adverse reactions Exact identifier application number: BLA020986 NOVOLOG INSULIN ASPART A-S Medication Solutions e172b4f8-9b25-4019-8e09-afc10b2f30c9 2023-12-09 Warnings, Adverse reactions Exact identifier application number: BLA020986 Insulin Aspart INSULIN ASPART Novo Nordisk Pharma, Inc. bee5b358-c863-420b-be73-ced2e920c499 2023-02-28 Warnings, Adverse reactions Exact identifier application number: BLA020986 Insulin Diluting Medium for NovoLog WATER INJECTION Novo Nordisk 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 2023-02-28 Warnings, Adverse reactions Exact identifier application number: BLA020986
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 020986 Novolog insulin aspart 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70518-3865-0 70518386500 5 SYRINGE, PLASTIC in 1 CARTON (70518-3865-0) / 3 mL in 1 SYRINGE, PLASTIC 2023-09-18 No No Current