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 | NuCare Pharmaceuticals,Inc. | 84899861-8fed-536d-e053-2991aa0a42b2 | 2024-09-26 | Boxed warning, Warnings, Adverse reactions | ANDA040596 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | a4fbc2d8-19b3-4556-b0b9-6e7a14cd4c36 | 2024-09-13 | Boxed warning, Warnings, Adverse reactions | ANDA040596 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 07914b6e-c40f-44be-a1db-8724c70f99b6 | 2024-08-15 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | ea490539-007b-47b1-bef9-22de02ae7c64 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | ANDA040596 992447 R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | a4b3da5b-1129-43c2-bf22-3a29c3fae116 | 2024-07-30 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 8749824b-6d66-430d-e053-2995a90a2db8 | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | ANDA040596 68071-4865-6 68071-4865-4 68071-4865 68071486506 992447 1ae1b7ed-1e35-1077-e063-6394a90a791e 8749824b-6d66-430d-e053-2995a90a2db8 R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 7e5715cf-056f-4095-e053-2991aa0ad3e5 | 2024-06-12 | Warnings, Adverse reactions | 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 4bf3912c-8339-401e-9711-dad6acf15f11 | 2024-06-05 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| PHENERGAN | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 481866da-a712-48a5-853f-8e84aacaab6d | 2024-05-20 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride and Codeine Phosphate | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | Bryant Ranch Prepack | df2c24ba-1c88-4ec3-b2a1-801358ec645c | 2024-04-16 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | b0d5abba-6fae-4f3c-b990-dd9c83c7b5a9 | 2024-04-10 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 365138a6-28d8-4881-a3e9-02c80aaf83e8 | 2024-04-10 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | da246971-20b8-b46e-8366-9700d3604cf1 | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | ANDA040596 992438 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Asclemed USA, Inc. | b4985d9d-1aa0-4b36-bc98-6a5410ad9bad | 2024-02-26 | Boxed warning, Warnings, Adverse reactions | ANDA040596 992475 992447 992438 R61ZEH7I1I |
| PROMETHAZINE HCI | PROMETHAZINE HCI | HF Acquisition Co. LLC, DBA HealthFirst | 744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a | 2024-02-22 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| PROMETHAZINE HCI | PROMETHAZINE HCI | HF Acquisition Co. LLC, DBA HealthFirst | 7447e8c6-c198-cd2d-e053-2a91aa0a3895 | 2024-02-22 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | A-S Medication Solutions | e451cb8d-f856-479f-bee9-4cccab210b1e | 2024-02-12 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | XGen Pharmaceuticals DJB, Inc. | b6f6698f-f23c-452a-9b38-bbb96ab88ae4 | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | XGen Pharmaceuticals DJB, Inc. | 1d02d52b-84bb-4e81-b352-125029eb39f6 | 2024-01-05 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | a7b1e8b2-6f20-4096-87c7-cf349ed4f7b9 | 2023-12-15 | Warnings, Adverse reactions | 992447 R61ZEH7I1I |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.