Home NDC 0186-1989 PULMICORT RESPULES
Product NDC 0186-1989
11-digit product format 001861989
Labeler code 0186
Product ID 0186-1989_76a8044c-b6f4-4da4-b855-a281fdca66b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Budesonide
Dosage form SUSPENSION
Route RESPIRATORY (INHALATION)
Labeler AstraZeneca Pharmaceuticals LP
Application NDA020929
Marketing category NDA
Marketing start 2000-09-08
Substance BUDESONIDE
Active strength .5 mg/2mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 123 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 2026-02-19 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020929-002 PULMICORT RESPULES 0.5MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020929-003 PULMICORT RESPULES 1MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020929-001 PULMICORT RESPULES 0.25MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020929-002 PULMICORT RESPULES 0.5MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020929-003 PULMICORT RESPULES 1MG/2ML SUSPENSION / INHALATION AN RLD, RS 2000-08-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020929-001 PULMICORT RESPULES 0.25MG/2ML SUSPENSION / INHALATION AN RLD 2000-08-08 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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…
Additional Listing Data#
Finished product Yes
Brand name base PULMICORT RESPULES
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUDESONIDE .5 mg/2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q3OKS62Q6X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 252559 Internal RxNorm lookup 349094 Internal RxNorm lookup 351109 Internal RxNorm lookup 616817 Internal RxNorm lookup 616819 Internal RxNorm lookup 616830 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0186-1989-04 PULMICORT RESPULES 5 in 1 POUCH SUSPENSION 5 23 0186-1989-04 PULMICORT RESPULES 6 in 1 CARTON SUSPENSION 6 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BUDESONIDE ACTIVE INGREDIENT Q3OKS62Q6X PULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP] 14 BUDESONIDE ACTIVE MOIETY Q3OKS62Q6X PULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP] 14 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL PULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP] 14 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP] 14 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP] 14 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X PULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP] 14 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP] 14 WATER INACTIVE INGREDIENT 059QF0KO0R PULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP] 14 BUDESONIDE ACTIVE INGREDIENT Q3OKS62Q6X PULMICORT RESPULES (BUDESONIDE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 BUDESONIDE ACTIVE MOIETY Q3OKS62Q6X PULMICORT RESPULES (BUDESONIDE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL PULMICORT RESPULES (BUDESONIDE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PULMICORT RESPULES (BUDESONIDE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PULMICORT RESPULES (BUDESONIDE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X PULMICORT RESPULES (BUDESONIDE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PULMICORT RESPULES (BUDESONIDE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R PULMICORT RESPULES (BUDESONIDE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0186-1989 PULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA PHARMACEUTICALS LP] 23 Current NDC, Legacy NDC, 2 package rows 20241120_33cd9834-76df-4f26-3fa2-aab6b9eee8f2.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0186-1989-04 00186198904 6 POUCH in 1 CARTON (0186-1989-04) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE 6 pouch 2000-09-08 0000-00-00 No No Current