Home DailyMed a0fa5324-4e1c-4af3-a66a-9a4e40b35e07 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 02:21:46 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020929-001 PULMICORT RESPULES BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 N020929-002 PULMICORT RESPULES BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 N020929-003 PULMICORT RESPULES BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 129 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 N020929-001 PULMICORT RESPULES 0.25MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020929-002 PULMICORT RESPULES 0.5MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020929-003 PULMICORT RESPULES 1MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020929-001 PULMICORT RESPULES 0.25MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020929-002 PULMICORT RESPULES 0.5MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020929-003 PULMICORT RESPULES 1MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020929-001 PULMICORT RESPULES 0.25MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020929-002 PULMICORT RESPULES 0.5MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020929-003 PULMICORT RESPULES 1MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020929-001 PULMICORT RESPULES 0.25MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020929-002 PULMICORT RESPULES 0.5MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020929-003 PULMICORT RESPULES 1MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020929-001 PULMICORT RESPULES 0.25MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020929-002 PULMICORT RESPULES 0.5MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020929-003 PULMICORT RESPULES 1MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020929-001 PULMICORT RESPULES 0.25MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020929-002 PULMICORT RESPULES 0.5MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020929-003 PULMICORT RESPULES 1MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020929-001 PULMICORT RESPULES 0.25MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020929-002 PULMICORT RESPULES 0.5MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020929-003 PULMICORT RESPULES 1MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020929-001 PULMICORT RESPULES 0.25MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020929-002 PULMICORT RESPULES 0.5MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020929-003 PULMICORT RESPULES 1MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020929-001 PULMICORT RESPULES 0.25MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020929-002 PULMICORT RESPULES 0.5MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020929-003 PULMICORT RESPULES 1MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020929-001 PULMICORT RESPULES 0.25MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020929-002 PULMICORT RESPULES 0.5MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020929-003 PULMICORT RESPULES 1MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020929-001 PULMICORT RESPULES 0.25MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020929-002 PULMICORT RESPULES 0.5MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020929-003 PULMICORT RESPULES 1MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020929-001 PULMICORT RESPULES 0.25MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020929-002 PULMICORT RESPULES 0.5MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020929-003 PULMICORT RESPULES 1MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020929-001 PULMICORT RESPULES 0.25MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020929-002 PULMICORT RESPULES 0.5MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020929-003 PULMICORT RESPULES 1MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020929-001 PULMICORT RESPULES 0.25MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N020929-001 7524834*PED 2019-05-11 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020929-001 6598603*PED 2019-06-23 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020929-001 6899099*PED 2019-06-23 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020929-002 7524834*PED 2019-05-11 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020929-002 6598603*PED 2019-06-23 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020929-002 6899099*PED 2019-06-23 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020929-003 7524834*PED 2019-05-11 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020929-003 6598603*PED 2019-06-23 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020929-003 6899099*PED 2019-06-23 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N020929-001 7524834*PED 2019-05-11 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020929-001 6598603*PED 2019-06-23 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020929-001 6899099*PED 2019-06-23 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020929-002 7524834*PED 2019-05-11 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020929-002 6598603*PED 2019-06-23 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020929-002 6899099*PED 2019-06-23 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020929-003 7524834*PED 2019-05-11 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020929-003 6598603*PED 2019-06-23 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020929-003 6899099*PED 2019-06-23 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020929-001 7524834*PED 2019-05-11 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020929-001 6598603*PED 2019-06-23 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020929-001 6899099*PED 2019-06-23 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020929-002 7524834*PED 2019-05-11 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020929-002 6598603*PED 2019-06-23 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020929-002 6899099*PED 2019-06-23 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020929-003 7524834*PED 2019-05-11 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020929-003 6598603*PED 2019-06-23 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020929-003 6899099*PED 2019-06-23 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020929-001 7524834*PED 2019-05-11 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020929-001 6598603*PED 2019-06-23 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020929-001 6899099*PED 2019-06-23 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020929-002 7524834*PED 2019-05-11 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020929-002 6598603*PED 2019-06-23 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020929-002 6899099*PED 2019-06-23 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020929-003 7524834*PED 2019-05-11 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020929-003 6598603*PED 2019-06-23 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020929-003 6899099*PED 2019-06-23 Pediatric extension ea99ee380514…
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.