Ipratropium Bromide
- Product NDC
- 68071-1550
- 11-digit product format
- 680711550
- Labeler code
- 68071
- Product ID
- 68071-1550_615bcd8c-b899-5463-e053-2991aa0a44a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ipratropium Bromide
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA075693
- Marketing category
- ANDA
- Marketing start
- 2011-03-01
- Marketing end
- 0000-00-00
- Substance
- IPRATROPIUM BROMIDE
- Active strength
- 1 mg/2.5mL
- Pharmacologic classes
- Anticholinergic [EPC],Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 product | product | 68071-1550 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 68071-1550 | 68071-1550-6 | 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 |
|---|---|---|---|---|---|---|---|
| A075693-001 | IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | 0.02% | SOLUTION / INHALATION | AN | RS | 2001-01-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075693-001 | AN |
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 | A075693-001 | IPRATROPIUM BROMIDE | 0.02% | SOLUTION / INHALATION | AN | RS | 2001-01-26 | 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 | A075693-001 | AN | 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 |
|---|---|---|---|---|---|---|
| Ipratropium Bromide | IPRATROPIUM BROMIDE | Cardinal Health 107, LLC | 6b730dd7-4d93-403a-bfd2-fa0efa298b75 | 2026-07-24 | Warnings, Adverse reactions | 075693 ANDA075693 |
| Ipratropium Bromide | IPRATROPIUM BROMIDE | Cardinal Health 107, LLC | 51350fab-a919-4d97-9d0c-d9dc7286244c | 2026-06-02 | Warnings, Adverse reactions | 075693 ANDA075693 |
| Ipratropium Bromide | IPRATROPIUM BROMIDE | Redpharm Drug | 52c63e41-dbbc-d9d7-e063-6294a90a30c9 | 2026-05-27 | Warnings, Adverse reactions | 075693 ANDA075693 |
| Ipratropium Bromide | IPRATROPIUM BROMIDE | Ritedose Pharmaceuticals, LLC | 22479633-624a-4251-ad3c-1dcba5d503fb | 2025-12-10 | Warnings, Adverse reactions | 075693 ANDA075693 |
| Ipratropium Bromide | IPRATROPIUM BROMIDE | NuCare Pharmaceuticals, Inc. | 2b9b619a-5e2a-73ef-e063-6394a90a97fe | 2025-01-13 | Warnings, Adverse reactions | 075693 ANDA075693 |
| Ipratropium Bromide | IPRATROPIUM BROMIDE | A-S Medication Solutions | 7159cf05-da58-4eb9-9e6d-a7f24eec5f46 | 2025-01-08 | Warnings, Adverse reactions | 075693 ANDA075693 |
| Ipratropium Bromide | IPRATROPIUM BROMIDE | American Health Packaging | 8927f392-4c88-4ac1-a934-c444ecf6b2c8 | 2024-06-03 | Warnings, Adverse reactions | 075693 ANDA075693 |
| Ipratropium Bromide | IPRATROPIUM BROMIDE | A-S Medication Solutions | 9f7b2f09-e831-4e15-b226-5cef3b613bd1 | 2023-02-16 | Warnings, Adverse reactions | 075693 ANDA075693 |
| Ipratropium Bromide | IPRATROPIUM BROMIDE | Mylan Pharmaceuticals Inc. | f625d3e3-c175-4d9a-99ea-dab410b262f1 | 2013-06-24 | Warnings, Adverse reactions | 075693 ANDA075693 |