NDC 00591-0385 - HYDROCODONE BITARTRATE AND ACETAMINOPHEN
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
- 00591-0385
- Manufacturer
- Keltman Pharmaceuticals Inc.
- Effective date
- 2010-12-10
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| hydrocodone bitartrate and acetaminophen tablet | Keltman Pharmaceuticals Inc. | 2010-12-10 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| acetaminophen for children | ACETAMINOPHEN | NuCare Pharmaceutiacals,Inc. | 5d7ef1d2-d970-7b01-e053-2991aa0a1311 | 2024-06-04 | Warnings | 362O9ITL9D |
| CareOne Infants Acetaminophen | ACETAMINOPHEN | American Sales Company | 0a28a4f1-d947-489b-be28-36ba10b581cf | 2024-06-01 | Warnings | 362O9ITL9D |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 4a873428-bb5a-4e48-9185-2a27f289110d | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 88d05136-7b04-4b25-af1c-6bc72fdbcbd7 | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 96173ce4-4836-43ae-9797-5246f830643a | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 3791abd3-fcdf-4c8d-b46d-db6e5c805770 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 0c85d1b8-ea42-421d-a305-4d338b47150f | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Bryant Ranch Prepack | 77fb237f-28b5-486b-b9ef-cb324d5cc0bd | 2024-05-30 | Warnings | 362O9ITL9D |
| Excedrin Migraine | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | A-S Medication Solutions | d012ed1d-b256-48ec-b988-f226c2c5ae9e | 2024-05-29 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Bryant Ranch Prepack | b5053cf5-209d-4106-afc2-cf9af85f4a69 | 2024-05-29 | Warnings | 362O9ITL9D |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 71b1a9be-3231-4b09-a195-d5893104bd4a | 2024-05-23 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| topcare infants pain and fever | ACETAMINOPHEN | Topco Associates LLC | f129bc0e-1ef1-42a8-8668-2ee88ffc85e3 | 2024-05-23 | Warnings | 362O9ITL9D |
| Good Neighbor Pharmacy Childrens Pain and Fever | ACETAMINOPHEN | Amerisource Bergen | 074fdf65-f6ce-46d4-87cc-46911c01cca5 | 2024-05-23 | Warnings | 362O9ITL9D |
| Nighttime Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | United Natural Foods, Inc. dba UNFI | 1aba9b7c-8328-4a9f-8ce2-39648b2d8ae4 | 2024-05-23 | Warnings | 362O9ITL9D |
| Mucus Relief Cold Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | e61ab02d-f932-403f-a4f7-0ca354607223 | 2024-05-23 | Warnings | 362O9ITL9D |
| Daytime Cold and Flu Relief Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | e4f9a846-ab72-4508-b0c5-f7911af2f3d7 | 2024-05-23 | Warnings | 362O9ITL9D |
| DG Health Childrens Pain and Fever | ACETAMINOPHEN | Dolgencorp, LLC | 779cf607-245f-408a-81e8-8000c0ea4c4a | 2024-05-22 | Warnings | 362O9ITL9D |
| good sense pain and fever infants | ACETAMINOPHEN | L. Perrigo Company | 7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb4 | 2024-05-21 | Warnings | 362O9ITL9D |
| Extra Strength Night Time Pain Medicine | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Geri-Care Pharmaceutical Corp | 2b8f83ed-1ca9-49ac-9b2a-2609b68200f9 | 2024-05-21 | Warnings | 362O9ITL9D |
| Acetaminophen Solution | ACETAMINOPHEN | Patrin Pharma, Inc. | 52ae729b-2255-420c-8db8-cabdc2b74796 | 2024-05-21 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.