Budesonide
- Product NDC
- 0093-6816
- 11-digit product format
- 000936816
- Labeler code
- 0093
- Product ID
- 0093-6816_551a929a-3517-4e58-9df6-f9bfb0f2f3be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- SUSPENSION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA077519
- Marketing category
- ANDA
- Marketing start
- 2019-01-11
- Substance
- BUDESONIDE
- Active strength
- .5 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Budesonide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUDESONIDE | .5 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q3OKS62Q6X |
| Rxcui | 349094, 351109 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BUDESONIDE | ACTIVE INGREDIENT | Q3OKS62Q6X | BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 8 | |
| BUDESONIDE | ACTIVE MOIETY | Q3OKS62Q6X | BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 8 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 8 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 8 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 8 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 8 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 8 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 8 | |
| BUDESONIDE | ACTIVE INGREDIENT | Q3OKS62Q6X | BUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| BUDESONIDE | ACTIVE MOIETY | Q3OKS62Q6X | BUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | BUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | BUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | BUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | BUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | BUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| BUDESONIDE | ACTIVE INGREDIENT | Q3OKS62Q6X | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| BUDESONIDE | ACTIVE MOIETY | Q3OKS62Q6X | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-6816 | BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA, INC.] | 13 | Current NDC, Legacy NDC, 5 package rows | 20210626_2414058b-5d39-42f2-915f-03a5e1101ab5.zip |
| 0093-6816 | BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20210626_4f126a29-38f7-4c4c-8978-37e72b289902.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0093-6816-19 | 00093681619 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | | | | | Historical |
| 0093-6816-45 | 00093681645 | 5 in 1 POUCH | | | | | | Historical |
| 0093-6816-55 | 00093681655 | 30 POUCH in 1 CARTON (0093-6816-55) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE | 30 pouch | 2019-01-11 | 0000-00-00 | No | No | Current |
| 0093-6816-73 | 00093681673 | 6 POUCH in 1 CARTON (0093-6816-73) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-6816-45) / 2 mL in 1 VIAL, SINGLE-DOSE (0093-6816-19) | 6 pouch | 2008-11-19 | 0000-00-00 | No | No | Current |
| 0093-6816-76 | 00093681676 | 2 POUCH in 1 CARTON (0093-6816-76) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE | 2 pouch | 2008-11-19 | 0000-00-00 | No | No | Current |