Home DailyMed 3ee43311-b5c7-4ff4-9b4e-0bb237681390 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:34:56
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 16 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019631-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-002 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;200MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-003 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;330MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-004 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION AP 1988-02-24 N019631-005 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;900MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-006 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-007 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;200MG/100ML INJECTABLE / INJECTION AP 1988-02-24 N019631-008 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;330MG/100ML INJECTABLE / INJECTION AP 1988-02-24 N019631-009 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;450MG/100ML INJECTABLE / INJECTION AP 1988-02-24 N019631-010 DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;900MG/100ML INJECTABLE / INJECTION AP 1988-02-24 N019631-011 DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 10GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-012 DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 10GM/100ML;200MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-013 DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 10GM/100ML;330MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-014 DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 10GM/100ML;450MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-015 DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 10GM/100ML;900MG/100ML INJECTABLE / INJECTION 1988-02-24 N019631-016 DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 3.3GM/100ML;300MG/100ML INJECTABLE / INJECTION 1990-01-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 18 · 688 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N019631-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 2.5GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-002 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 2.5GM/100ML;200MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-003 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 2.5GM/100ML;330MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-004 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION AP 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-005 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 2.5GM/100ML;900MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-006 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-007 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 5GM/100ML;200MG/100ML INJECTABLE / INJECTION AP 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-008 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 5GM/100ML;330MG/100ML INJECTABLE / INJECTION AP 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-009 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5GM/100ML;450MG/100ML INJECTABLE / INJECTION AP 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-010 DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 5GM/100ML;900MG/100ML INJECTABLE / INJECTION AP 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-011 DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 10GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-012 DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 10GM/100ML;200MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-013 DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 10GM/100ML;330MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-014 DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 10GM/100ML;450MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-015 DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 10GM/100ML;900MG/100ML INJECTABLE / INJECTION 1988-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019631-016 DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 3.3GM/100ML;300MG/100ML INJECTABLE / INJECTION 1990-01-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019631-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 2.5GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-002 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 2.5GM/100ML;200MG/100ML INJECTABLE / INJECTION 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-003 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 2.5GM/100ML;330MG/100ML INJECTABLE / INJECTION 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-004 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION AP 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-005 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 2.5GM/100ML;900MG/100ML INJECTABLE / INJECTION 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-006 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-007 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 5GM/100ML;200MG/100ML INJECTABLE / INJECTION AP 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-008 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 5GM/100ML;330MG/100ML INJECTABLE / INJECTION AP 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-009 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5GM/100ML;450MG/100ML INJECTABLE / INJECTION AP 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-010 DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 5GM/100ML;900MG/100ML INJECTABLE / INJECTION AP 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-011 DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 10GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-012 DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 10GM/100ML;200MG/100ML INJECTABLE / INJECTION 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-013 DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 10GM/100ML;330MG/100ML INJECTABLE / INJECTION 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-014 DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 10GM/100ML;450MG/100ML INJECTABLE / INJECTION 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-015 DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 10GM/100ML;900MG/100ML INJECTABLE / INJECTION 1988-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019631-016 DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 3.3GM/100ML;300MG/100ML INJECTABLE / INJECTION 1990-01-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019631-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 2.5GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019631-002 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 2.5GM/100ML;200MG/100ML INJECTABLE / INJECTION 1988-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019631-003 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 2.5GM/100ML;330MG/100ML INJECTABLE / INJECTION 1988-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019631-004 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION AP 1988-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019631-005 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 2.5GM/100ML;900MG/100ML INJECTABLE / INJECTION 1988-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019631-006 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML INJECTABLE / INJECTION 1988-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019631-007 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 5GM/100ML;200MG/100ML INJECTABLE / INJECTION AP 1988-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019631-008 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 5GM/100ML;330MG/100ML INJECTABLE / INJECTION AP 1988-02-24 011fe1cb6892…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 215 observed states.
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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.