Home DailyMed c74f8b9b-9bea-42c1-a8cb-88a43becbf96 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 02:39:19 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 44 .
Orange Book products# Current product rows page 1 of 1 · 8 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N013684-001 OSMITROL 5% IN WATER MANNITOL 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-002 OSMITROL 10% IN WATER MANNITOL 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-003 OSMITROL 20% IN WATER MANNITOL 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-004 OSMITROL 15% IN WATER MANNITOL 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER MANNITOL 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER MANNITOL 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER MANNITOL 20GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER MANNITOL 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 8 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 9 · 352 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 2026-10-15 13:18:30 2026-09 N013684-001 OSMITROL 5% IN WATER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 N013684-002 OSMITROL 10% IN WATER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 N013684-003 OSMITROL 20% IN WATER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 N013684-004 OSMITROL 15% IN WATER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 c2088c7a36db…2026-09-14 22:38:34 2026-08 N013684-001 OSMITROL 5% IN WATER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N013684-002 OSMITROL 10% IN WATER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N013684-003 OSMITROL 20% IN WATER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N013684-004 OSMITROL 15% IN WATER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 N013684-001 OSMITROL 5% IN WATER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N013684-002 OSMITROL 10% IN WATER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N013684-003 OSMITROL 20% IN WATER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N013684-004 OSMITROL 15% IN WATER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N013684-001 OSMITROL 5% IN WATER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N013684-002 OSMITROL 10% IN WATER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N013684-003 OSMITROL 20% IN WATER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N013684-004 OSMITROL 15% IN WATER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N013684-001 OSMITROL 5% IN WATER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N013684-002 OSMITROL 10% IN WATER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N013684-003 OSMITROL 20% IN WATER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N013684-004 OSMITROL 15% IN WATER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 9 · 352 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.