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 |
|---|---|---|---|---|---|---|
| dg health migraine relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Dolgencorp Inc | 673d42d8-b484-4232-bc91-19d83db63550 | 2022-06-07 | Warnings | 362O9ITL9D |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Proficient Rx LP | d9fa3057-c7a5-46cf-a79e-abf99a4f804d | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| topcare 8 hr arthritis pain relief | ACETAMINOPHEN | Topco Associates LLC | 0d427360-ff9d-4e98-b218-6eb6c015dc6a | 2022-05-23 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Asclemed USA, Inc. | 5c00f98f-dcab-4bdb-901e-02eb873dea31 | 2022-05-10 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Asclemed USA, Inc. | 3e89f02d-b6e7-4641-82d4-f756518a8914 | 2022-05-05 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Trezix | ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE | Proficient Rx LP | 45c3c2a1-6a89-471e-b6d4-5a4cd73b987a | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | c6210466-5feb-45d9-b637-b3f482bc3c2b | 2022-05-01 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | 199d4915-cb3b-48f3-835d-a45d04a5c940 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Proficient Rx LP | 75b50751-5237-4e3e-b7ee-1605c0602f3b | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| basic care acetaminophen | ACETAMINOPHEN | Amazon.com Services LLC | b0c55ac4-0b1a-4411-9df3-6bb64e20ea22 | 2022-03-23 | Warnings | 362O9ITL9D |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | b3c229a4-c772-70fb-e053-2a95a90a72db | 2022-03-11 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Solupharm Pharmazeutische Erzeugnisse GmbH | d92be8ae-3173-0a9d-e053-2995a90abc63 | 2022-03-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Civica, Inc. | 1b5ca3e0-ce08-4e11-9385-9ec22e5abb5b | 2022-02-15 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Proficient Rx LP | 7a2219a8-8aaf-44ad-9808-b67923df361a | 2022-02-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Asclemed USA, Inc. | 52693021-f60f-43bc-9b05-43db18621346 | 2022-01-14 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Cold Medicine | COLD MEDICINE | Allegiant Health | 443fbc44-2c33-4316-ad31-dcc5a5aa8f52 | 2021-11-23 | Warnings | 362O9ITL9D |
| Pain Relief Extra Strength | PAIN RELIEF | Allegiant Health | d41d2319-8eed-4df9-813c-313497ceb8b4 | 2021-11-23 | Warnings | 362O9ITL9D |
| Pain Relief PM Extra Strength | PAIN RELIEF PM | Allegiant Health | 4c9969be-a01f-4ca4-800a-e404229ce28b | 2021-11-23 | Warnings | 362O9ITL9D |
| Tension Headache Relief | TENSION HEADACHE RELIEF | Allegiant Health | 9d348550-060b-410f-8c1e-8f43d00b860e | 2021-11-22 | Warnings | 362O9ITL9D |
| NOCOLD-F | ACETAMINOPHENE. CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Lydia Co., Ltd. | d0b20c56-de2a-1489-e053-2995a90a6a06 | 2021-11-13 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.