PULMICORT
- Product NDC
- 0186-0917
- 11-digit product format
- 001860917
- Labeler code
- 0186
- Product ID
- 0186-0917_62af6940-7a80-400c-b2e7-e7d6145df756
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- AEROSOL, POWDER
- Route
- RESPIRATORY (INHALATION)
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- NDA021949
- Marketing category
- NDA
- Marketing start
- 2007-03-19
- Marketing end
- 0000-00-00
- Substance
- BUDESONIDE
- Active strength
- 90 ug/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7816cdf6-b925-4282-bedd-11ae25d518a1 | Product name | 1 | 20250116 |
| d17a61d0-e77b-4bcb-ad22-343ff1a3ef4d | Product name | 2 | 20240424 |
| 9ab9f611-cedd-47ea-a83c-0489c8c04fc6 | Product name | 1 | 20231006 |
| c76bcd0f-25eb-471e-b970-1956c95c26c5 | Product name | 1 | 20230425 |
| a03aea00-1d8b-bfad-a82e-f52f68676f63 | Product name | 2 | 20221216 |
| 54a29484-7dde-4771-9547-005149321621 | Product name | 1 | 20220720 |
| 793b53dd-c0ea-da17-9ac0-fb5c4a6e0743 | Product name | 5 | 20211018 |
| 218c043e-94e5-4e66-a363-d0d446485bc6 | Product name | 2 | 20210512 |
| 7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a | Product name | 1 | 20210204 |
| 5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7 | Product name | 9 | 20210127 |
| da63bc8c-2e89-4044-89d6-1facbff5474e | Product name | 1 | 20200121 |
| 899766bc-33ce-8154-910d-12cb0889fb56 | Product name | 2 | 20150106 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0186-0917-06 | EA - Each | 0186-0917 | 0a2ef61f-5399-4f41-ae7b-364e12532536 | 1 | 2012-07-24 |
| 0186-0917-65 | EA - Each | 0186-0917 | ba21aea3-c18e-4efd-8907-69c87e0a886a | 1 | 2019-06-19 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BUDESONIDE | ACTIVE INGREDIENT | Q3OKS62Q6X | PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [ASTRAZENECA LP] | 14 | |
| BUDESONIDE | ACTIVE MOIETY | Q3OKS62Q6X | PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [ASTRAZENECA LP] | 14 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [ASTRAZENECA LP] | 14 | |
| BUDESONIDE | ACTIVE INGREDIENT | Q3OKS62Q6X | PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [REBEL DISTRIBUTORS CORP] | 1 | |
| BUDESONIDE | ACTIVE MOIETY | Q3OKS62Q6X | PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [REBEL DISTRIBUTORS CORP] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 966527 | budesonide 90 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT | PSN | 0950cd08-a48b-4376-9647-da22cf5a8a70 | 1 |
| 966529 | Pulmicort Flexhaler 90 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT | PSN | 0950cd08-a48b-4376-9647-da22cf5a8a70 | 1 |
| 966529 | 60 ACTUAT budesonide 0.09 MG/ACTUAT Dry Powder Inhaler [Pulmicort] | SBD | 0950cd08-a48b-4376-9647-da22cf5a8a70 | 1 |
| 966527 | 60 ACTUAT budesonide 0.09 MG/ACTUAT Dry Powder Inhaler | SCD | 0950cd08-a48b-4376-9647-da22cf5a8a70 | 1 |
| 966527 | budesonide 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUAT | SY | 0950cd08-a48b-4376-9647-da22cf5a8a70 | 1 |
| 966527 | budesonide 90 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 0950cd08-a48b-4376-9647-da22cf5a8a70 | 1 |
| 966529 | Pulmicort 90 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 0950cd08-a48b-4376-9647-da22cf5a8a70 | 1 |
| 966529 | Pulmicort Flexhaler 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUAT | SY | 0950cd08-a48b-4376-9647-da22cf5a8a70 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0186-0917-06 | 00186091706 | 1 INHALER in 1 CARTON (0186-0917-06) > 60 AEROSOL, POWDER in 1 INHALER | 1 inhaler | 2007-03-19 | 0000-00-00 | No | No | Current |
| 0186-0917-65 | 00186091765 | 1 INHALER in 1 CARTON (0186-0917-65) > 60 AEROSOL, POWDER in 1 INHALER | 1 inhaler | 2007-03-19 | 2022-09-30 | No | No | Current |