NDC 68071-4737-02 - 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
- 68071-4737
- Requested NDC
- 68071-4737-02
- Package NDCs from labels
- 68071-4737-6, 68071-4737-3, 68071-4737-2, 68071-4737-02
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2026-06-30
- 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. | 2026-06-30 | HUMAN PRESCRIPTION DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-4737-6 | 2024-06-12 | C162847 | 48780-1 | ba0f9c33-2ed7-a910-e053-dadaa90a0b85 | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 68071-4737-6 | 2024-06-12 | C162847 | 48780-1 | ba0f9c33-2ed7-a910-e053-dadaa90a0b85 | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 68071-4737-6 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-2ed7-a910-e053-dadaa90a0b85 | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 68071-4737-6 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-2ed7-a910-e053-dadaa90a0b85 | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 68071-4737-6 | 2021-02-17 | C162847 | 48780-1 | ba0f9c33-2ed7-a910-e053-dadaa90a0b85 | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 68071-4737-6 | 2021-02-17 | C162847 | 48780-1 | ba0f9c33-2ed7-a910-e053-dadaa90a0b85 | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 68071-4737-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2ed7-a910-e053-dadaa90a0b85 | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
| 68071-4737-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2ed7-a910-e053-dadaa90a0b85 | PROMETHAZINE HYDROCHLORIDE TABLETS, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-4737-3 | PROMETHAZINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | 4 | |
| 68071-4737-6 | PROMETHAZINE HYDROCHLORIDE | 6 in 1 BOTTLE | TABLET | 6 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-4737 | PROMETHAZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240614_804e2525-d61f-7bed-e053-2991aa0a5daa.zip |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 6bcaa89f-5f14-dc45-e053-2a91aa0aac54 | 2026-07-30 | Warnings, Adverse reactions | ANDA040712 992447 R61ZEH7I1I |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION | ATLANTIC BIOLOGICALS CORP. | 3983d6d3-8bf4-4a88-962f-9bf72fd6e685 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Coupler LLC | 55f618d1-4466-3200-e063-6394a90a89a8 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 9e4e57fa-4ce3-4b7b-be5a-381801ed0386 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Sportpharm LLC | 4156e780-7ecf-bcae-e063-6394a90a2ae2 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 992475 992447 992438 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | ASCLEMED USA INC. | 4d30e587-6d59-4cf5-ab45-c7639f759df9 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 992475 992447 992438 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 5590f356-0904-58f6-e063-6294a90a6ad5 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 992447 R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 804e2525-d61f-7bed-e053-2991aa0a5daa | 2026-06-30 | Warnings, Adverse reactions | ANDA040712 68071-4737-3 68071-4737-2 68071-4737-6 68071-4737 68071473702 992447 557ecafd-4236-de90-e063-6294a90a6798 804e2525-d61f-7bed-e053-2991aa0a5daa R61ZEH7I1I |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Advagen Pharma Ltd | 8b60eff2-5759-4bc3-ac16-5ff80aa153a0 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Camber Pharmaceuticals, Inc. | 6a2cd2d6-6e0f-4b2d-be7a-8b99627f4453 | 2026-06-09 | Warnings, Adverse reactions | R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | e6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488 | 2026-06-05 | Warnings, Adverse reactions | ANDA040712 992447 R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | f9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c47 | 2026-06-04 | Warnings, Adverse reactions | ANDA040712 992438 R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8 | 2026-05-22 | Warnings, Adverse reactions | ANDA040712 992447 R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | f93ca67d-362a-473f-8296-2952da77c074 | 2026-05-22 | Warnings, Adverse reactions | ANDA040712 992475 R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d | 2026-05-22 | Warnings, Adverse reactions | ANDA040712 992438 R61ZEH7I1I |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Atlantic Biologicals Corp. | 5022379d-05ef-63f2-e063-6294a90a2189 | 2026-04-23 | Warnings, Adverse reactions | R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Atlantic Biologicals Corp. | 4f99bbd5-02f7-2fed-e063-6394a90a6355 | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | bf951b5b-6e38-44a9-895e-0d60c6b9d343 | 2026-03-27 | Warnings, Adverse reactions | 992438 R61ZEH7I1I |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Bryant Ranch Prepack | 709519cb-d124-4469-b329-b67e1bba214b | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 81fd29a9-c090-49ba-8b48-bd3656ca0c92 | 2026-03-19 | Warnings, Adverse reactions | 992447 R61ZEH7I1I |