SYMBICORT
- Product NDC
- 50090-4509
- 11-digit product format
- 500904509
- Labeler code
- 50090
- Product ID
- 50090-4509_f086f511-6eb9-47f7-bf1b-8e04a70909be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide and Formoterol Fumarate Dihydrate
- Dosage form
- AEROSOL
- Route
- RESPIRATORY (INHALATION)
- Labeler
- A-S Medication Solutions
- Application
- NDA021929
- Marketing category
- NDA
- Marketing start
- 2007-05-29
- Substance
- BUDESONIDE; FORMOTEROL FUMARATE
- Active strength
- 160; 4.5 ug/1; ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SYMBICORT
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUDESONIDE | 160 ug/1 |
| FORMOTEROL FUMARATE | 4.5 ug/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | Q3OKS62Q6X, W34SHF8J2K |
| Rxcui | 1246304, 1246306 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0c06c4f4-ea2d-4e6a-a22a-0cf292716367 | Product name | 4 | 20250303 |
| 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 |
| 1cbe9071-502b-482d-9c24-839b43446576 | Product name | 1 | 20200123 |
| da63bc8c-2e89-4044-89d6-1facbff5474e | Product name | 1 | 20200121 |
| 58f15a44-d9d2-4d61-a39d-7f0223302a8f | Product name | 1 | 20190702 |
| ce066c73-ca6f-49fc-83d4-d3cf6728e8a1 | Product name | 1 | 20160616 |
| 899766bc-33ce-8154-910d-12cb0889fb56 | Product name | 2 | 20150106 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4509-0 | SYMBICORT | 1 in 1 POUCH | AEROSOL | 1 | 8 | |
| 50090-4509-0 | SYMBICORT | 1 in 1 CARTON | AEROSOL | 1 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-4509-0 | GM - Gram | 50090-4509 | b7638758-6f40-48bc-8b9b-12f34f9c0701 | 1 | 2024-07-12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4509 | SYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [A-S MEDICATION SOLUTIONS] | 8 | Current NDC, 2 package rows | 20240629_805764a1-65e1-4117-ac4a-7a54c3986cfe.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1246304 | budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations | PSN | 805764a1-65e1-4117-ac4a-7a54c3986cfe | 8 |
| 1246306 | Symbicort 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations | PSN | 805764a1-65e1-4117-ac4a-7a54c3986cfe | 8 |
| 1246306 | 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Symbicort] | SBD | 805764a1-65e1-4117-ac4a-7a54c3986cfe | 8 |
| 1246304 | 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler | SCD | 805764a1-65e1-4117-ac4a-7a54c3986cfe | 8 |
| 1246304 | budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT | SY | 805764a1-65e1-4117-ac4a-7a54c3986cfe | 8 |
| 1246304 | budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT | SY | 805764a1-65e1-4117-ac4a-7a54c3986cfe | 8 |
| 1246306 | Symbicort 160/4.5 (budesonide / formoterol fumarate) Metered Dose Inhaler, 120 ACTUAT | SY | 805764a1-65e1-4117-ac4a-7a54c3986cfe | 8 |
| 1246306 | Symbicort 160/4.5 Metered Dose Inhaler, 120 ACTUAT | SY | 805764a1-65e1-4117-ac4a-7a54c3986cfe | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-4509-0 | 50090450900 | 1 POUCH in 1 CARTON (50090-4509-0) / 1 AEROSOL in 1 POUCH | 1 pouch | 2019-09-04 | No | No | Historical |