NDC 68071-4865-06 - Promethazine Hydrochloride
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 68071-4865
- Requested NDC
- 68071-4865-06
- Package NDCs from labels
- 68071-4865-4, 68071-4865-6, 68071-4865-06
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2024-06-14
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Promethazine Hydrochloride Tablets USP | NuCare Pharmaceuticals,Inc. | 2024-06-14 | HUMAN PRESCRIPTION DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-4865-6 | 2021-02-17 | C162847 | 48780-1 | ba0f9c33-3b10-a910-e053-dadaa90a0b85 | Promethazine Hydrochloride Tablets USP |
| 68071-4865-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3b10-a910-e053-dadaa90a0b85 | Promethazine Hydrochloride Tablets USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-4865-4 | Promethazine Hydrochloride | 4 in 1 BOTTLE | TABLET | 4 | 6 | |
| 68071-4865-6 | Promethazine Hydrochloride | 6 in 1 BOTTLE | TABLET | 6 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-4865 | PROMETHAZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240616_8749824b-6d66-430d-e053-2995a90a2db8.zip |
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 |
|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Proficient Rx LP | 29a8b172-1bad-40db-8d73-1fe7fb309cff | 2022-04-01 | Warnings, Adverse reactions | 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Proficient Rx LP | 08bf9fbf-cc21-41a0-9e81-ec498aa64170 | 2019-11-01 | Warnings, Adverse reactions | 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Actavis Pharma, Inc. | a32255f0-0077-489e-bdc6-869aca8cd434 | 2016-12-01 | Warnings, Adverse reactions | 992475 992447 R61ZEH7I1I |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.