Promethazine Hydrochloride
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Promethazine Hydrochloride
- Generic name
- PROMETHAZINE HYDROCHLORIDE
- Manufacturer
- Zydus Lifesciences Limited
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 4eaa8291-9cde-4205-857b-925ea8d618ba
- SPL ID
- 800e2d40-d3af-43a0-9ea0-41e2d1d0e8b5
- Version
- 7
- Effective date
- 2024-12-04
- Source export date
- 2026-10-30
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-30/772d0e4623a189b47f3ab71d7d51f9b3c89c5526f4cf3d218e1c921bb964b80c/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
- Import run
- 20261102T182004Z
- Imported at
- 2026-11-02 18:28:44
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 040596 | derived:openfda.application_number |
| application number | ANDA040596 | openfda.application_number | |
| brand name | Promethazine Hydrochloride | openfda.brand_name | |
| generic name | PROMETHAZINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Zydus Lifesciences Limited | openfda.manufacturer_name | |
| ndc | package | 65841-042-01 | openfda.package_ndc |
| ndc | package | 65841-041-10 | openfda.package_ndc |
| ndc | package | 65841-040-05 | openfda.package_ndc |
| ndc | package | 65841-042-10 | openfda.package_ndc |
| ndc | package | 65841-042-05 | openfda.package_ndc |
| ndc | package | 65841-041-01 | openfda.package_ndc |
| ndc | package | 65841-041-05 | openfda.package_ndc |
| ndc | package | 65841-040-10 | openfda.package_ndc |
| ndc | package | 65841-040-01 | openfda.package_ndc |
| ndc | product | 65841-041 | openfda.product_ndc |
| ndc | product | 65841-040 | openfda.product_ndc |
| ndc | product | 65841-042 | openfda.product_ndc |
| ndc11 | package | 65841004210 | derived:openfda.package_ndc |
| ndc11 | package | 65841004001 | derived:openfda.package_ndc |
| ndc11 | package | 65841004005 | derived:openfda.package_ndc |
| ndc11 | package | 65841004205 | derived:openfda.package_ndc |
| ndc11 | package | 65841004110 | derived:openfda.package_ndc |
| ndc11 | package | 65841004201 | derived:openfda.package_ndc |
| ndc11 | package | 65841004101 | derived:openfda.package_ndc |
| ndc11 | package | 65841004105 | derived:openfda.package_ndc |
| ndc11 | package | 65841004010 | derived:openfda.package_ndc |
| rxcui | 992475 | openfda.rxcui | |
| rxcui | 992447 | openfda.rxcui | |
| rxcui | 992438 | openfda.rxcui | |
| spl id | 800e2d40-d3af-43a0-9ea0-41e2d1d0e8b5 | id | |
| spl set id | 4eaa8291-9cde-4205-857b-925ea8d618ba | set_id | |
| unii | R61ZEH7I1I | openfda.unii |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.