PULMICORT
- Product NDC
- 21695-291
- 11-digit product format
- 216950291
- Labeler code
- 21695
- Product ID
- 21695-291_0950cd08-a48b-4376-9647-da22cf5a8a70
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- AEROSOL, POWDER
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Rebel Distributors Corp
- Application
- NDA021949
- Marketing category
- NDA
- Marketing start
- 2010-07-30
- Marketing end
- 0000-00-00
- Substance
- BUDESONIDE
- Active strength
- 90 ug/1
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-291-01 | 2019-09-24 | C162847 | 48780-1 | 934fe258-47ee-48b1-e053-8cdaa90a720a | These highlights do not include all the information needed to use PULMICORT FLEXHALER™ safely and effectively. See full prescribing information for PULMICORT FLEXHALER™. PULMICORT FLEXHALER™ 90 MCG, 180 MCG (BUDESONIDE INHALATION POWDER) Initial U.S. Approval: 2006 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-291-01 | PULMICORTFLEXHALER | 1 in 1 CARTON | AEROSOL, POWDER | 1 | 1 | |
| 21695-291-01 | PULMICORTFLEXHALER | 60 in 1 INHALER | AEROSOL, POWDER | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-291-01 | EA - Each | 21695-291 | 4d235de4-f88b-42cc-bf9c-bc91ff33ee98 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| 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 | Status |
|---|---|---|---|
| 21695-291-01 | 21695029101 | 1 in 1 CARTON | Historical |