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 | Cranbury Pharmaceuticals, LLC | d32ea9db-11d4-400d-b7ef-dd0ec01b796d | 2025-12-12 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | ProPharma Distribution | 45b09a50-dab2-e83d-e063-6394a90aa813 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| promethazine hydrochloride | PROMETHAZINE HYDROCHLORIDE | ATLANTIC BIOLOGICALS CORP | 69934bbb-922c-4752-b253-f2f07340de8d | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | 46b869e2-9305-43ae-bb15-919a6d09b6ff | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Chartwell Governmental & Specialty RX, LLC. | e5d2156d-1f66-4fdf-a3ae-5e1325218c8b | 2025-11-21 | Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | American Health Packaging | a8fe4bc5-961b-4441-b8e2-ef93e4e137b6 | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | ANDA040596 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | American Health Packaging | 57b4bf23-c563-4357-9dcf-066cbc1280e4 | 2025-11-13 | Warnings, Adverse reactions | ANDA040596 992438 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Henry Schein, Inc. | d7675718-0a57-41ff-a771-79afc12150aa | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Henry Schein, Inc. | c525cb2c-9a01-4a9b-ad2c-08630719953d | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Cardinal Health 107, LLC | e16238dc-9292-49ac-b80f-8afeccb88bc5 | 2025-10-24 | Warnings, Adverse reactions | 992447 R61ZEH7I1I |
| PROMETHEGAN | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97 | 2025-10-20 | Boxed warning, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7d766cf7-a21c-4eaf-bbdc-00f2939ef19a | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Cosette Pharmaceuticals, Inc. | e7b336d9-b1df-4a08-9b67-754346d365f4 | 2025-09-23 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | A-S Medication Solutions | 87f9e9fb-5433-478b-9f23-e16883a9d2a9 | 2025-09-23 | Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Major Pharmaceuticals | 4cee8622-7d59-4794-8e32-54f7aac1d923 | 2025-09-22 | Warnings, Adverse reactions | 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | BluePoint Laboratories | 44cd6d46-fbb9-4836-9426-d8ce2cb6d66d | 2025-09-12 | Boxed warning, Warnings, Adverse reactions | ANDA040596 992475 992447 992438 R61ZEH7I1I |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | ANI Pharmaceuticals, Inc. | a52e210f-b99d-493e-b679-ec565c6ff72d | 2025-08-08 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 7a186bcd-ab8c-4695-8289-4cd33bb551cf | 2025-08-05 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 13d9e59d-eadb-41d5-9f47-9c11a6efb31c | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | d545105f-27dc-4820-b0b1-fcf17e0be0f0 | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.