Home DailyMed 9b2da0e8-5c43-4fb3-884a-4e28f062265c 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 02:19:13 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.
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.
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