Ibuprofen
- Product NDC
- 55700-446
- Requested package NDC
- 55700-446-30
- 11-digit product format
- 557000446
- Labeler code
- 55700
- Product ID
- 55700-446_c1af9352-c277-499c-9e24-ef955e0ac013
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA091625
- Marketing category
- ANDA
- Marketing start
- 2015-12-21
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 800 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 55700-446 | 55700-446-30 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091625-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | |
| A091625-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | |
| A091625-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091625-001 | AB |
| A091625-002 | AB |
| A091625-003 | AB |
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 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A091625-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A091625-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A091625-003 | AB | 1 | 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 | PD-Rx Pharmaceuticals, Inc. | d3a7ebef-f7ab-4b34-b62e-278a8deabf78 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | b81c6495-8b30-41ef-8a0f-4cbfd87f1eb4 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d8 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 57a1bf99-5aaf-432d-86ba-5f0e7cfab1a0 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | f1c88d74-09b0-4b14-baea-106fbbbc54bf | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | b6a6c940-daf6-4e0e-aefb-35cce87a9a55 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 421156d2-85dc-4680-b2b4-d15b67539e87 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 20078671-536f-4b0b-a079-f90ac186a670 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 1e6f3ce7-e8a3-40e8-8437-523ef5277b2e | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Unit Dose Solutions, Inc. | 5515661b-6373-2191-e063-6294a90a17e0 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | b40f39e4-a37c-4039-ae37-210c1c3c6235 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 51de1183-d226-4869-a00a-f6c74e126a39 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 25a94943-9acc-49c8-a4da-7e07bb2c35eb | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Northwind Health Company, LLC | ab80abe6-f7db-479b-e053-2a95a90a90e3 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Ascend Laboratories, LLC | 9ce036ef-a22d-4fca-9a62-1b10978f7b26 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 560e4e05-21e0-4b2a-ab2f-872b5dbb3901 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | QPharma Inc | fd8b82a7-96fe-8bf5-e053-6394a90a3935 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Granules Pharmaceuticals Inc. | 4aefcb3a-5dc8-b88e-e063-6294a90ac044 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| IBUPROFEN | IBUOROFEN | Direct_Rx | 90b8b80e-ab30-3590-e053-2a95a90a70ef | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Legacy Pharmaceutical Packaging, LLC | 5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-446-00 | EA - Each | 55700-446 | e983485c-842b-4128-aea6-632275d269d8 | 1 | 2016-12-07 |
| 55700-446-20 | EA - Each | 55700-446 | d540b3e8-9536-4d3c-9b2d-f7d4b104c355 | 1 | 2016-12-07 |
| 55700-446-21 | EA - Each | 55700-446 | 6c5bf977-8366-4cbe-b359-0bf81aa78a7c | 1 | 2016-12-07 |
| 55700-446-30 | EA - Each | 55700-446 | bbdb0459-3f63-429f-a027-78f22f0bdebc | 1 | 2016-12-07 |
| 55700-446-40 | EA - Each | 55700-446 | 6cd251ac-a58e-4bd4-b8b0-51c275eb310a | 1 | 2016-12-07 |
| 55700-446-60 | EA - Each | 55700-446 | 9475fead-7d13-4d92-a1c8-c6ed09eef2e7 | 1 | 2016-12-07 |
| 55700-446-90 | EA - Each | 55700-446 | ca3b3572-c449-421f-bf44-58a0267b2b6e | 1 | 2016-12-07 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55700-446-30 | 55700044630 | 30 TABLET, FILM COATED in 1 BOTTLE (55700-446-30) | 2016-10-17 | 0000-00-00 | No | No | Current |