PULMICORT RESPULES

Product NDC
0186-1988
11-digit product format
001861988
Labeler code
0186
Product ID
0186-1988_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
.25 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020929-001PULMICORT RESPULESBUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08
N020929-002PULMICORT RESPULESBUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08
N020929-003PULMICORT RESPULESBUDESONIDE1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N020929-001AN
N020929-002AN
N020929-003AN

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-088072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020929-001AN1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020929-002AN1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020929-003AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020929-001AN131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020929-002AN131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020929-003AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020929-001AN16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020929-002AN16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020929-003AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020929-001AN1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020929-002AN1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020929-003AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020929-001AN1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020929-002AN1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020929-003AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020929-001AN103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020929-002AN103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020929-003AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020929-001AN12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020929-002AN12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020929-003AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020929-001AN15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020929-002AN15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020929-003AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020929-001AN1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020929-002AN1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020929-003AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020929-001AN1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020929-002AN1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020929-003AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020929-001AN179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020929-002AN179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020929-003AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020929-001AN1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020929-002AN1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020929-003AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020929-001AN11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020929-002AN11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020929-003AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020929-001AN18072bd15b7f6…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020929-0017524834*PED2019-05-11Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020929-0016598603*PED2019-06-23Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020929-0016899099*PED2019-06-23Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020929-0027524834*PED2019-05-11Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020929-0026598603*PED2019-06-23Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020929-0026899099*PED2019-06-23Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020929-0037524834*PED2019-05-11Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020929-0036598603*PED2019-06-23Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020929-0036899099*PED2019-06-23Pediatric extension74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N020929-0017524834*PED2019-05-11Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020929-0016598603*PED2019-06-23Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020929-0016899099*PED2019-06-23Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020929-0027524834*PED2019-05-11Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020929-0026598603*PED2019-06-23Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020929-0026899099*PED2019-06-23Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020929-0037524834*PED2019-05-11Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020929-0036598603*PED2019-06-23Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020929-0036899099*PED2019-06-23Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N020929-0017524834*PED2019-05-11Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020929-0016598603*PED2019-06-23Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020929-0016899099*PED2019-06-23Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020929-0027524834*PED2019-05-11Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020929-0026598603*PED2019-06-23Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020929-0026899099*PED2019-06-23Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020929-0037524834*PED2019-05-11Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020929-0036598603*PED2019-06-23Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020929-0036899099*PED2019-06-23Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N020929-0017524834*PED2019-05-11Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020929-0016598603*PED2019-06-23Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020929-0016899099*PED2019-06-23Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020929-0027524834*PED2019-05-11Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020929-0026598603*PED2019-06-23Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020929-0026899099*PED2019-06-23Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020929-0037524834*PED2019-05-11Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020929-0036598603*PED2019-06-23Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020929-0036899099*PED2019-06-23Pediatric extensionea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
PULMICORT RESPULES
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE.25 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q3OKS62Q6XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
252559Internal RxNorm lookup
349094Internal RxNorm lookup
351109Internal RxNorm lookup
616817Internal RxNorm lookup
616819Internal RxNorm lookup
616830Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
33cd9834-76df-4f26-3fa2-aab6b9eee8f2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7816cdf6-b925-4282-bedd-11ae25d518a1Product name120250116
d17a61d0-e77b-4bcb-ad22-343ff1a3ef4dProduct name220240424
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
54a29484-7dde-4771-9547-005149321621Product name120220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743Product name520211018
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
218c043e-94e5-4e66-a363-d0d446485bc6Product name220210512
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7Product name920210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
da63bc8c-2e89-4044-89d6-1facbff5474eProduct name120200121
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
899766bc-33ce-8154-910d-12cb0889fb56Product name220150106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0186-1988-04PULMICORT RESPULES5 in 1 POUCHSUSPENSION523
0186-1988-04PULMICORT RESPULES6 in 1 CARTONSUSPENSION623

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0186-1988-04ML - Milliliter0186-19889d9918dd-db20-4610-ad23-3cf4f359f2e112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUDESONIDEACTIVE INGREDIENTQ3OKS62Q6XPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
BUDESONIDEACTIVE MOIETYQ3OKS62Q6XPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
WATERINACTIVE INGREDIENT059QF0KO0RPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
BUDESONIDEACTIVE INGREDIENTQ3OKS62Q6XPULMICORT RESPULES (BUDESONIDE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
BUDESONIDEACTIVE MOIETYQ3OKS62Q6XPULMICORT RESPULES (BUDESONIDE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPULMICORT RESPULES (BUDESONIDE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPULMICORT RESPULES (BUDESONIDE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPULMICORT RESPULES (BUDESONIDE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPULMICORT RESPULES (BUDESONIDE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPULMICORT RESPULES (BUDESONIDE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RPULMICORT RESPULES (BUDESONIDE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0186-1988PULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA PHARMACEUTICALS LP]23Current NDC, Legacy NDC, 2 package rows20241120_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PULMICORT RESPULESBUDESONIDEAstraZeneca Pharmaceuticals LP33cd9834-76df-4f26-3fa2-aab6b9eee8f22019-10-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 020929
application number: NDA020929
ndc (product): 0186-1988

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSN33cd9834-76df-4f26-3fa2-aab6b9eee8f223
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSN33cd9834-76df-4f26-3fa2-aab6b9eee8f223
252559budesonide 1 MG in 2 ML Inhalation SuspensionPSN33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616830Pulmicort Respules 0.25 MG in 2 ML Inhalation SuspensionPSN33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616817Pulmicort Respules 0.5 MG in 2 ML Inhalation SuspensionPSN33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616819Pulmicort Respules 1 MG in 2 ML Inhalation SuspensionPSN33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616830budesonide 0.125 MG/ML Inhalation Suspension [Pulmicort]SBD33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616817budesonide 0.25 MG/ML Inhalation Suspension [Pulmicort]SBD33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616819budesonide 0.5 MG/ML Inhalation Suspension [Pulmicort]SBD33cd9834-76df-4f26-3fa2-aab6b9eee8f223
349094budesonide 0.125 MG/ML Inhalation SuspensionSCD33cd9834-76df-4f26-3fa2-aab6b9eee8f223
351109budesonide 0.25 MG/ML Inhalation SuspensionSCD33cd9834-76df-4f26-3fa2-aab6b9eee8f223
252559budesonide 0.5 MG/ML Inhalation SuspensionSCD33cd9834-76df-4f26-3fa2-aab6b9eee8f223
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
252559budesonide 1 MG per 2 ML Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616830Pulmicort Respules 0.125 MG/ACTUAT Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616830Pulmicort Respules 0.25 MG per 2 ML Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616817Pulmicort Respules 0.25 MG/ML Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616817Pulmicort Respules 0.5 MG per 2 ML Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616819Pulmicort Respules 0.5 MG/ML Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616819Pulmicort Respules 1 MG per 2 ML Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSN2e0fa140-85a0-42db-ba15-a068120076b42
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSN2e0fa140-85a0-42db-ba15-a068120076b42
616830Pulmicort Respules 0.25 MG in 2 ML Inhalation SuspensionPSN2e0fa140-85a0-42db-ba15-a068120076b42
616817Pulmicort Respules 0.5 MG in 2 ML Inhalation SuspensionPSN2e0fa140-85a0-42db-ba15-a068120076b42
616830budesonide 0.125 MG/ML Inhalation Suspension [Pulmicort]SBD2e0fa140-85a0-42db-ba15-a068120076b42
616817budesonide 0.25 MG/ML Inhalation Suspension [Pulmicort]SBD2e0fa140-85a0-42db-ba15-a068120076b42
349094budesonide 0.125 MG/ML Inhalation SuspensionSCD2e0fa140-85a0-42db-ba15-a068120076b42
351109budesonide 0.25 MG/ML Inhalation SuspensionSCD2e0fa140-85a0-42db-ba15-a068120076b42
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSY2e0fa140-85a0-42db-ba15-a068120076b42
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSY2e0fa140-85a0-42db-ba15-a068120076b42
616830Pulmicort Respules 0.125 MG/ACTUAT Inhalation SuspensionSY2e0fa140-85a0-42db-ba15-a068120076b42
616830Pulmicort Respules 0.25 MG per 2 ML Inhalation SuspensionSY2e0fa140-85a0-42db-ba15-a068120076b42
616817Pulmicort Respules 0.25 MG/ML Inhalation SuspensionSY2e0fa140-85a0-42db-ba15-a068120076b42
616817Pulmicort Respules 0.5 MG per 2 ML Inhalation SuspensionSY2e0fa140-85a0-42db-ba15-a068120076b42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0186-1988-04001861988046 POUCH in 1 CARTON (0186-1988-04) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE6 pouch2000-09-080000-00-00NoNoCurrent