Ipratropium Bromide
- Product NDC
- 68788-0547
- 11-digit product format
- 687880547
- Labeler code
- 68788
- Product ID
- 68788-0547_a971f9da-ab0b-4b02-8e58-d794671c5327
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ipratropium Bromide
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Preferred Pharmaceuticals, Inc
- Application
- ANDA075562
- Marketing category
- ANDA
- Marketing start
- 2013-02-22
- 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
- 2019-12-31
- 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 | 68788-0547 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 68788-0547 | 68788-0547-2 | 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 |
|---|---|---|---|---|---|---|---|
| A075562-001 | IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | 0.02% | SOLUTION / INHALATION | AN | 2001-09-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075562-001 | 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 | A075562-001 | IPRATROPIUM BROMIDE | 0.02% | SOLUTION / INHALATION | AN | 2001-09-27 | 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 | A075562-001 | 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 | Rising Pharma Holdings, Inc. | 3249aea8-a395-f09f-e063-6294a90a2d8b | 2026-07-16 | Warnings, Adverse reactions | 075562 ANDA075562 |
| Ipratropium Bromide | IPRATROPIUM BROMIDE | Chartwell RX, LLC | 1e3d4faa-cf6e-460b-b1e0-fcc8094505fa | 2025-12-02 | Warnings, Adverse reactions | 075562 ANDA075562 |
| Ipratropium Bromide | IPRATROPIUM BROMIDE | Nephron Pharmaceuticals Corporation | db8095db-d1fd-4099-9fb1-d1ad4e284976 | 2025-04-08 | Warnings, Adverse reactions | 075562 ANDA075562 |