HOMATROPINE HYDROBROMIDE OPHTHALMIC
- Product NDC
- 59390-192
- Requested package NDC
- 59390-192-05
- 11-digit product format
- 593900192
- Labeler code
- 59390
- Product ID
- 59390-192_5190a5bc-5820-4874-bbe7-32576266a72f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Homatropine Hydrobromide
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Altaire Pharmaceuticals Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2018-06-01
- Marketing end
- 0000-00-00
- Substance
- HOMATROPINE HYDROBROMIDE
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 59390-192 | 59390-192-05 | D | Discontinued by firm | 2026-10-05 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59390-192-05 | HOMATROPINE HYDROBROMIDE OPHTHALMIC | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 5 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59390-192-05 | ML - Milliliter | 59390-192 | 3adde5d7-c07f-452b-9727-fa07a0c97558 | 1 | 2013-06-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| HOMATROPINE HYDROBROMIDE OPHTHALMIC | HOMATROPINE HYDROBROMIDE | Altaire Pharmaceuticals Inc. | f3ffd601-182f-4f04-b1cc-8175bc2e32fe | 2022-10-28 | Warnings, Adverse reactions | 59390-192-05 59390-192 59390019205 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 992757 | homatropine HBr 5 % Ophthalmic Solution | PSN | f3ffd601-182f-4f04-b1cc-8175bc2e32fe | 5 |
| 992757 | homatropine hydrobromide 50 MG/ML Ophthalmic Solution | SCD | f3ffd601-182f-4f04-b1cc-8175bc2e32fe | 5 |
| 992757 | homatropine hydrobromide 5 % Ophthalmic Solution | SY | f3ffd601-182f-4f04-b1cc-8175bc2e32fe | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59390-192-05 | 59390019205 | 5 mL in 1 BOTTLE, PLASTIC (59390-192-05) | 5 ml | 2018-06-01 | 0000-00-00 | No | No | Current |