IPRATROPIUM BROMIDE
- Product NDC
- 85766-242
- Requested package NDC
- 85766-242-15
- 11-digit product format
- 857660242
- Labeler code
- 85766
- Product ID
- 85766-242_568fa03b-f12a-a131-e063-6294a90a66b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IPRATROPIUM BROMIDE
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Sportpharm LLC
- Application
- ANDA217886
- Marketing category
- ANDA
- Marketing start
- 2025-07-03
- Substance
- IPRATROPIUM BROMIDE
- Active strength
- 42 ug/1
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217886-001 | IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | 0.042MG/SPRAY | SPRAY, METERED / NASAL | AB | 2025-01-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217886-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A217886-001 | IPRATROPIUM BROMIDE | 0.042MG/SPRAY | SPRAY, METERED / NASAL | AB | 2025-01-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A217886-001 | IPRATROPIUM BROMIDE | 0.042MG/SPRAY | SPRAY, METERED / NASAL | AB | 2025-01-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217886-001 | IPRATROPIUM BROMIDE | 0.042MG/SPRAY | SPRAY, METERED / NASAL | AB | 2025-01-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217886-001 | IPRATROPIUM BROMIDE | 0.042MG/SPRAY | SPRAY, METERED / NASAL | AB | 2025-01-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217886-001 | IPRATROPIUM BROMIDE | 0.042MG/SPRAY | SPRAY, METERED / NASAL | AB | 2025-01-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217886-001 | IPRATROPIUM BROMIDE | 0.042MG/SPRAY | SPRAY, METERED / NASAL | AB | 2025-01-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217886-001 | IPRATROPIUM BROMIDE | 0.042MG/SPRAY | SPRAY, METERED / NASAL | AB | 2025-01-27 | b8a1b40f171c… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217886-001 | IPRATROPIUM BROMIDE | 0.042MG/SPRAY | SPRAY, METERED / NASAL | AB | 2025-01-27 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A217886-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A217886-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A217886-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217886-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217886-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217886-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217886-001 | AB | 1 | b8a1b40f171c… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217886-001 | AB | 1 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- IPRATROPIUM BROMIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| IPRATROPIUM BROMIDE | 42 ug/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| J697UZ2A9J | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1797844 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7e8fdd92-1e55-47e2-aa85-e48cfebbb8d7 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | Sportpharm LLC | 7e8fdd92-1e55-47e2-aa85-e48cfebbb8d7 | 2026-07-14 | Warnings, Adverse reactions | 217886 ANDA217886 85766-242-15 85766-242 85766024215 |
| IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | Lupin Pharmaceuticals, Inc. | ee0ac556-8a23-4d5c-a5da-881c1fc6a339 | 2026-01-08 | Warnings, Adverse reactions | 217886 ANDA217886 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 85766-242-15 | 85766024215 | 1 BOTTLE, SPRAY in 1 CARTON (85766-242-15) / 165 SPRAY, METERED in 1 BOTTLE, SPRAY | 2026-07-14 | No | No | Current |