FDA.reportPublic FDA data

Sterile Diluent

Product NDC
0002-0800
Requested package NDC
0002-0800-00
11-digit product format
000020800
Labeler code
0002
Product ID
0002-0800_d0a38a0f-9d29-44eb-bfd1-c83cbcba1008
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diluent
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA020563
Marketing category
BLA
Marketing start
1987-07-10
Substance
WATER
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage0002-08000002-0800-00UNFINISHEDActive or certified unfinished drug listing2026-08-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…

Additional Listing Data#

Finished product
Yes
Brand name base
Sterile Diluent
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WATER1 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GFX7QIS1IIInternal UNII lookup
059QF0KO0RInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
a42609d2-d76b-4c21-bc65-ace5fa0da69dProduct name120210105
0c5ba5d1-c81f-5bcc-49a8-b8e264edfb14Product name320200325
4477e8cc-8057-4880-8829-dfea528a2efaProduct name220200325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-0800-01Sterile Diluent10 mL in 1 VIALINJECTION, SOLUTION1086
0002-0800-01Sterile Diluent1 in 1 CARTONINJECTION, SOLUTION186

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Insulin lisproACTIVE INGREDIENTGFX7QIS1IIHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
Insulin lisproACTIVE MOIETYGFX7QIS1IIHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
GlycerinINACTIVE INGREDIENTPDC6A3C0OXHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
MetacresolINACTIVE INGREDIENTGGO4Y809LOHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
PhenolINACTIVE INGREDIENT339NCG44TVHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
TromethamineINACTIVE INGREDIENT023C2WHX2VHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
WaterINACTIVE INGREDIENT059QF0KO0RHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
ZincINACTIVE INGREDIENTJ41CSQ7QDSHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-0800HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG JUNIOR KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG TEMPO PEN (INSULIN LISPRO) INJECTION, SOLUTION STERILE DILUENT (DILUENT) INJECTION, SOLUTION HUMALOG TEMPO PEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]84Current NDC, Legacy NDC, 2 package rows20250523_c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Humalog KwikPenINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-01-09Warnings, Adverse reactionsExact identifier
application number: BLA020563
ndc (product): 0002-0800
Insulin LisproINSULIN LISPROEli Lilly and Company97d5e596-aae1-42c9-ae89-c3780959c4672025-06-17Warnings, Adverse reactionsExact identifier
application number: BLA020563
HUMALOGINSULIN LISPROA-S Medication Solutionsc6b8ff07-d3e2-457f-8a38-b60de60adf752025-04-01Warnings, Adverse reactionsExact identifier
application number: BLA020563
Insulin LisproINSULIN LISPROA-S Medication Solutions2be14cbb-197a-4da8-82c8-2443594e7f6f2024-05-31Warnings, Adverse reactionsExact identifier
application number: BLA020563
HUMALOGINSULIN LISPROA-S Medication Solutions6ee01d2e-3525-4aa9-8ec1-5fb0f63dd47c2024-02-15Warnings, Adverse reactionsExact identifier
application number: BLA020563
Humalog KwikPenINSULIN LISPROA-S Medication Solutions51d3dc11-52b9-4296-a2f4-58c770d4448d2024-01-24Warnings, Adverse reactionsExact identifier
application number: BLA020563

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020563Humaloginsulin lispro351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1652646HumaLOG 100 UNT/ML in 3 ML CartridgePSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652640HumaLOG 100 UNT/ML in 3 ML Pen InjectorPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
865098HumaLOG 100 UNT/ML Injectable SolutionPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652242HumaLOG 200 UNT/ML in 3 ML Pen InjectorPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1926332HumaLOG Junior 100 UNT/ML in 3 ML Pen InjectorPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
2621572HumaLOG Tempo 100 UNT/ML in 3 ML Pen InjectorPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652644insulin lispro 100 UNT/ML in 3 ML CartridgePSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652639insulin lispro 100 UNT/ML in 3 ML Pen InjectorPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
2621571insulin lispro 100 UNT/ML in 3 ML Pen Injector with SensorPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1926331insulin lispro 100 UNT/ML in 3 ML Pen Injector, 0.5 UNT DosesPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
242120insulin lispro 100 UNT/ML Injectable SolutionPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652239insulin lispro 200 UNT/ML in 3 ML Pen InjectorPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
19263320.5 UNT Doses 3 ML insulin lispro 100 UNT/ML Pen Injector [Humalog]SBDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16526463 ML insulin lispro 100 UNT/ML Cartridge [Humalog]SBDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16526403 ML insulin lispro 100 UNT/ML Pen Injector [Humalog]SBDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16522423 ML insulin lispro 200 UNT/ML Pen Injector [Humalog]SBDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
865098insulin lispro 100 UNT/ML Injectable Solution [Humalog]SBDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
2621572Sensor 3 ML insulin lispro 100 UNT/ML Pen Injector [Humalog]SBDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
19263310.5 UNT Doses 3 ML insulin lispro 100 UNT/ML Pen InjectorSCDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16526443 ML insulin lispro 100 UNT/ML CartridgeSCDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16526393 ML insulin lispro 100 UNT/ML Pen InjectorSCDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16522393 ML insulin lispro 200 UNT/ML Pen InjectorSCDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
242120insulin lispro 100 UNT/ML Injectable SolutionSCDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
2621571Sensor 3 ML insulin lispro 100 UNT/ML Pen InjectorSCDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
19263320.5 UNT Doses 3 ML Humalog 100 UNT/ML Pen InjectorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16526463 ML Humalog 100 UNT/ML CartridgeSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16526403 ML Humalog 100 UNT/ML Pen InjectorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16522423 ML Humalog 200 UNT/ML Pen InjectorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
865098Humalog 100 UNT/ML Injectable SolutionSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652646Humalog 100 UNT/ML per 3 ML CartridgeSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
2621572Humalog 100 UNT/ML per 3 ML Pen Injector with SensorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
2621572Humalog 300 UNT per 3 ML Pen Injector with SensorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652242Humalog 600 UNT per 3 ML KwikPenSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1926332Humalog Junior KwikPen 100 UNT/ML per 3 ML Pen InjectorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652640Humalog KwikPen 100 UNT/ML per 3 ML Pen InjectorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652644insulin lispro 100 UNT/ML per 3 ML CartridgeSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652639insulin lispro 100 UNT/ML per 3 ML Pen InjectorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
2621571insulin lispro 100 UNT/ML per 3 ML Pen Injector with SensorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1926331insulin lispro 100 UNT/ML per 3 ML Pen Injector, 0.5 UNT DosesSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
2621571insulin lispro 300 UNT per 3 ML Pen Injector with SensorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
242120insulin, analog lispro 100 UNT/ML Injectable SolutionSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
0002-0800-000000208000010 mL in 1 VIAL, MULTI-DOSE (0002-0800-00)10 ml10-JUL-87Current