Ibuprofen
- Product NDC
- 50804-750
- Requested package NDC
- 50804-750-40
- 11-digit product format
- 508040750
- Labeler code
- 50804
- Product ID
- 50804-750_189fd6c7-79be-42c2-b4ea-912fc103c5aa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Good Sense (Geiss, Destin & Dunn, Inc.)
- Application
- ANDA206999
- Marketing category
- ANDA
- Marketing start
- 2018-06-30
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 200 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 50804-750 | 50804-750-40 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206999-001 | IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2017-12-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A206999-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2017-12-21 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ibuprofen | IBUPROFEN | Rite Aid Corporation | 47657d95-4a54-49c2-8273-86b413b8f41e | 2025-07-30 | Warnings | 206999 ANDA206999 |
| Dolex Flex | IBUPROFEN | Pharmadel LLC | 822d9def-504c-9beb-e053-2991aa0a280e | 2023-09-13 | Warnings | 206999 ANDA206999 |
| Ibuprofen | IBUPROFEN | Costco Wholesale | eb62ed66-cafd-4d09-acc9-b9abf748ba85 | 2022-10-11 | Warnings | 206999 ANDA206999 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50804-750-20 | 2023-02-11 | C162847 | 48780-1 | f386c649-9d3d-0266-e053-dadaa90a7c1a | Drug Facts |
| 50804-750-40 | 2023-02-11 | C162847 | 48780-1 | f386c649-9d3d-0266-e053-dadaa90a7c1a | Drug Facts |
| 50804-750-20 | 2023-01-30 | C162847 | 48780-1 | f386c649-9d3d-0266-e053-dadaa90a7c1a | Drug Facts |
| 50804-750-40 | 2023-01-30 | C162847 | 48780-1 | f386c649-9d3d-0266-e053-dadaa90a7c1a | Drug Facts |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50804-750-40 | 50804075040 | 1 BOTTLE, PLASTIC in 1 BOX (50804-750-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | 2018-06-30 | 0000-00-00 | No | No | Current |