Budesonide
- Product NDC
- 11822-1700
- 11-digit product format
- 118221700
- Labeler code
- 11822
- Product ID
- 11822-1700_89b38e1f-9469-c307-5b8f-6060e8c70432
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Rite Aid
- Application
- ANDA078949
- Marketing category
- ANDA
- Marketing start
- 2019-10-10
- Marketing end
- 0000-00-00
- Substance
- BUDESONIDE
- Active strength
- 32 ug/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 11822-1700 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 11822-1700 | 11822-1700-1 | D | Discontinued by firm | 2026-08-11 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078949-002 | BUDESONIDE | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A078949-002 | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED / NASAL | 2015-11-20 | cb3db0bc1861… |
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 Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-1700 | BUDESONIDE SPRAY, METERED [RITE AID] | 6 | Legacy NDC | 20241004_a49e054e-e9ba-7103-3ab0-d4dc930c382f.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Budesonide | BUDESONIDE | Rugby Laboratories | 04eb9e98-1323-353f-3fd7-2d317dfac526 | 2026-02-27 | Warnings | 078949 ANDA078949 |
| Budesonide | BUDESONIDE | Walgreens | 9d519bf3-8d9b-5208-13c5-308edc24aca7 | 2026-01-21 | Warnings | 078949 ANDA078949 |
| Budesonide | BUDESONIDE | CVS Pharmacy | b2650d29-c011-48f1-a7f4-040011d4563d | 2026-01-21 | Warnings | 078949 ANDA078949 |
| Budesonide | BUDESONIDE | Rugby Laboratories | b83af99e-1619-48ed-a033-e5207033f77e | 2025-12-09 | Warnings | 078949 ANDA078949 |
| Budesonide | BUDESONIDE | Apotex Corp. | f1aac35a-bc72-dd68-8179-8661354589cb | 2025-09-22 | Warnings | 078949 ANDA078949 |
| Budesonide | BUDESONIDE | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | d9ba3859-90af-0390-11be-c04834e27d61 | 2025-05-16 | Warnings | 078949 ANDA078949 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 11822-1700-1 | 11822170001 | 1 BOTTLE, SPRAY in 1 CARTON (11822-1700-1) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY | 2019-10-10 | 0000-00-00 | No | No | Current |