PULMICORT
- Product NDC
- 85612-010
- 11-digit product format
- 856120010
- Labeler code
- 85612
- Product ID
- 85612-010_a035bb8f-2fe9-4a86-af53-32196ffc0361
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- AEROSOL, POWDER
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Rubicon Holdings Inc.
- Application
- NDA021949
- Marketing category
- NDA
- Marketing start
- 2025-07-01
- Substance
- BUDESONIDE
- Active strength
- 90 ug/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PULMICORT
- Brand name suffix
- FLEXHALER
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUDESONIDE | 90 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q3OKS62Q6X |
| Rxcui | 966522, 966524, 966527, 966529 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85612-010-01 | PULMICORTFLEXHALER | 1 in 1 CARTON | AEROSOL, POWDER | 1 | | 2 |
| 85612-010-01 | PULMICORTFLEXHALER | 60 in 1 INHALER | AEROSOL, POWDER | 60 | | 2 |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 966522 | budesonide 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT | PSN | ae1105cd-69fc-4c15-937f-c535304341c2 | 2 |
| 966527 | budesonide 90 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT | PSN | ae1105cd-69fc-4c15-937f-c535304341c2 | 2 |
| 966524 | Pulmicort Flexhaler 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT | PSN | ae1105cd-69fc-4c15-937f-c535304341c2 | 2 |
| 966529 | Pulmicort Flexhaler 90 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT | PSN | ae1105cd-69fc-4c15-937f-c535304341c2 | 2 |
| 966524 | 120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler [Pulmicort] | SBD | ae1105cd-69fc-4c15-937f-c535304341c2 | 2 |
| 966529 | 60 ACTUAT budesonide 0.09 MG/ACTUAT Dry Powder Inhaler [Pulmicort] | SBD | ae1105cd-69fc-4c15-937f-c535304341c2 | 2 |
| 966522 | 120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler | SCD | ae1105cd-69fc-4c15-937f-c535304341c2 | 2 |
| 966527 | 60 ACTUAT budesonide 0.09 MG/ACTUAT Dry Powder Inhaler | SCD | ae1105cd-69fc-4c15-937f-c535304341c2 | 2 |
| 966527 | budesonide 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUAT | SY | ae1105cd-69fc-4c15-937f-c535304341c2 | 2 |
| 966522 | budesonide 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUAT | SY | ae1105cd-69fc-4c15-937f-c535304341c2 | 2 |
| 966522 | budesonide 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUATS | SY | ae1105cd-69fc-4c15-937f-c535304341c2 | 2 |
| 966527 | budesonide 90 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | ae1105cd-69fc-4c15-937f-c535304341c2 | 2 |
| 966529 | Pulmicort 90 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | ae1105cd-69fc-4c15-937f-c535304341c2 | 2 |
| 966529 | Pulmicort Flexhaler 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUAT | SY | ae1105cd-69fc-4c15-937f-c535304341c2 | 2 |
| 966524 | Pulmicort Flexhaler 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUAT | SY | ae1105cd-69fc-4c15-937f-c535304341c2 | 2 |
| 966524 | Pulmicort Flexhaler 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUAT | SY | ae1105cd-69fc-4c15-937f-c535304341c2 | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85612-010-01 | 85612001001 | 1 INHALER in 1 CARTON (85612-010-01) / 60 AEROSOL, POWDER in 1 INHALER | 1 inhaler | 2025-07-01 | No | No | Historical |