Budesonide
- Product NDC
- 0487-9601
- 11-digit product format
- 004879601
- Labeler code
- 0487
- Product ID
- 0487-9601_32635b5d-cc62-710c-e063-6294a90a2802
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUDESONIDE
- Dosage form
- INHALANT
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Nephron Pharmaceuticals Corporation
- Application
- ANDA078202
- Marketing category
- ANDA
- Marketing start
- 2013-10-01
- Substance
- BUDESONIDE
- Active strength
- .25 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 |
|---|---|
| BUDESONIDE | .25 mg/2mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | Q3OKS62Q6X |
| Rxcui | 349094, 351109 |
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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0487-9601-01 | Budesonide | 6 in 1 CARTON | INHALANT | 6 | 8 | |
| 0487-9601-01 | Budesonide | 5 in 1 POUCH | INHALANT | 5 | 8 | |
| 0487-9601-30 | Budesonide | 30 in 1 CARTON | INHALANT | 30 | 8 | |
| 0487-9601-30 | Budesonide | 1 in 1 POUCH | INHALANT | 1 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0487-9601-01 | ML - Milliliter | 0487-9601 | 478a62be-a366-429d-b5c0-3382d6b13754 | 1 | 2016-07-19 |
| 0487-9601-30 | ML - Milliliter | 0487-9601 | e2dfc99b-f67f-4fed-a85c-646c85e09f55 | 1 | 2016-07-19 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BUDESONIDE | ACTIVE INGREDIENT | Q3OKS62Q6X | BUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION] | 1 | |
| BUDESONIDE | ACTIVE MOIETY | Q3OKS62Q6X | BUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | BUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION] | 1 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | BUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION] | 1 | |
| Polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | BUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION] | 1 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | BUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION] | 1 | |
| Sodium Citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | BUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | BUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 349094 | budesonide 0.25 MG in 2 ML Inhalation Suspension | PSN | f12043df-f9a3-4edb-88f8-dd176c1a141c | 8 |
| 351109 | budesonide 0.5 MG in 2 ML Inhalation Suspension | PSN | f12043df-f9a3-4edb-88f8-dd176c1a141c | 8 |
| 349094 | budesonide 0.125 MG/ML Inhalation Suspension | SCD | f12043df-f9a3-4edb-88f8-dd176c1a141c | 8 |
| 351109 | budesonide 0.25 MG/ML Inhalation Suspension | SCD | f12043df-f9a3-4edb-88f8-dd176c1a141c | 8 |
| 349094 | budesonide 0.25 MG per 2 ML Inhalation Suspension | SY | f12043df-f9a3-4edb-88f8-dd176c1a141c | 8 |
| 351109 | budesonide 0.5 MG per 2 ML Inhalation Suspension | SY | f12043df-f9a3-4edb-88f8-dd176c1a141c | 8 |
| 349094 | budesonide 0.25 MG in 2 ML Inhalation Suspension | PSN | 521a79d0-4d93-45f7-8feb-8d2b502dd216 | 2 |
| 349094 | budesonide 0.125 MG/ML Inhalation Suspension | SCD | 521a79d0-4d93-45f7-8feb-8d2b502dd216 | 2 |
| 349094 | budesonide 0.25 MG per 2 ML Inhalation Suspension | SY | 521a79d0-4d93-45f7-8feb-8d2b502dd216 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0487-9601-01 | 00487960101 | 6 POUCH in 1 CARTON (0487-9601-01) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE | 6 pouch | 2013-10-01 | 0000-00-00 | No | No | Current |
| 0487-9601-30 | 00487960130 | 30 POUCH in 1 CARTON (0487-9601-30) / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE | 30 pouch | 2013-10-01 | 0000-00-00 | No | No | Current |