NDC 54868-4237-9 - 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
- 54868-4237
- Requested NDC
- 54868-4237-9
- Package NDCs from labels
- 54868-4237-0, 54868-4237-4, 54868-4237-9
- Manufacturer
- Physicians Total Care, Inc.
- Effective date
- 2014-04-03
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII | Physicians Total Care, Inc. | 2014-04-03 | HUMAN PRESCRIPTION DRUG LABEL |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2012-07-24 | Indexing - Billing Unit |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54868-4237-0 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 20 in 1 BOTTLE | TABLET | 20 | 9 | |
| 54868-4237-4 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 30 in 1 BOTTLE | TABLET | 30 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54868-4237 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.] | 9 | 2 package rows | 20140403_8f5d00de-3b9b-46d4-b374-1cf329a4c1db.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54868-4237-0 | EA - Each | 54868-4237 | bb31b128-549e-4fdb-b9b0-543112f180ff | 1 | 2012-07-24 |
| 54868-4237-1 | EA - Each | 54868-4237 | 6d53310e-8693-4fcc-95a2-996e1379b41e | 1 | 2012-07-24 |
| 54868-4237-2 | EA - Each | 54868-4237 | 441549e5-4acf-4495-8e66-8c3ab0757f48 | 1 | 2012-07-24 |
| 54868-4237-3 | EA - Each | 54868-4237 | eaf77609-d88d-4670-9e0f-b97e06503175 | 1 | 2012-07-24 |
| 54868-4237-4 | EA - Each | 54868-4237 | 462f01cc-d536-466e-8c3e-e9115b6806d0 | 1 | 2012-07-24 |
| 54868-4237-5 | EA - Each | 54868-4237 | 54f6ca8c-9534-4202-aaa0-2fd2d5cbebeb | 1 | 2012-07-24 |
| 54868-4237-6 | EA - Each | 54868-4237 | 3292499c-9552-4e91-978a-77ed8d3649c1 | 1 | 2012-07-24 |
| 54868-4237-7 | EA - Each | 54868-4237 | 304bcfcf-be65-4392-8f0c-cb64b50aef44 | 1 | 2012-07-24 |
| 54868-4237-8 | EA - Each | 54868-4237 | d85056c3-fc5b-460b-ba98-3c98ed26cb1a | 1 | 2012-07-24 |
| 54868-4237-9 | EA - Each | 54868-4237 | d9477990-2170-4bd4-b78a-0f9227da55b7 | 1 | 2012-07-24 |
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 |
|---|---|---|---|---|---|---|
| QUALITY CHOICE NightTime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | da06e994-6848-4c1e-9432-31de5e626ea4 | 2024-03-02 | Warnings | 362O9ITL9D |
| QUALITY CHOICE DayTime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | 417c4fa9-6458-40d0-b22a-2415194e250f | 2024-03-02 | Warnings | 362O9ITL9D |
| DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Aurohealth LLC | 8eaa0eec-cc52-4f1f-8ddb-06c54d577ce2 | 2024-03-01 | Warnings | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Lupin Pharmaceuticals,Inc. | 916ff456-a27e-49dc-a312-274126a8c30c | 2024-02-29 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| SEDALMEX FORTE | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Belmora LLC | 33b3508e-4caa-4d05-9b15-cb82a2ee2d4d | 2024-02-28 | Warnings | 362O9ITL9D |
| MAX relief junior | ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | 396903dc-ae2d-4bf4-b1fd-0017b84abef9 | 2024-02-28 | Warnings | 362O9ITL9D |
| MAX relief junior | ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | 44730cbd-5b98-49bd-b3b8-6fecb0ccd153 | 2024-02-28 | Warnings | 362O9ITL9D |
| Theraflu Severe Cold Relief Daytime Berry Burst | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | ebbb2f4b-ba84-40ad-96f6-60225119a33b | 2024-02-27 | Warnings | 362O9ITL9D |
| Mucus Relief Sinus Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AMERISOURCE BERGEN | 1c93c45d-1141-4599-83ba-6d3b38f9ffc4 | 2024-02-23 | Warnings | 362O9ITL9D |
| Pain Relief | ACETAMINOPHEN | AMERISOURCE BERGEN | 2b923a97-836c-4dac-a8c0-3047a35fb62e | 2024-02-23 | Warnings | 362O9ITL9D |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 3dc293c9-736b-4bd8-b993-ff83b9909bcd | 2024-02-23 | Warnings | 362O9ITL9D |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | BJWC (Berkley & Jensen / BJ's) | b20a08f3-c9c0-4bd9-8ce0-acb932b5bb86 | 2024-02-22 | Warnings | 362O9ITL9D |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | LGM PHARMA SOLUTIONS, LLC | f6548126-faa1-4f53-8e0b-bc1b743de04d | 2024-02-21 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Basic Care Dual Action | ACETAMINOPHEN, IBUPROFEN | Amazon.com Services LLC | 7e27f5cb-8728-400f-82c5-0984276aa5dd | 2024-02-20 | Warnings | 362O9ITL9D |
| Kidney Drainage | SOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUM | Deseret Biologicals, Inc. | a030afc6-9248-4e6a-a814-bd700c053e5c | 2024-02-20 | Warnings | ETJ7Z6XBU4 |
| M-PAP | ACETAMINOPHEN | Bryant Ranch Prepack | 31a41976-7f65-42d7-acf5-de9c2c5ca58e | 2024-02-20 | Warnings | 362O9ITL9D |
| Cough | IPECACUANHA, STICTA PULMONARIA, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, ACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, SILICEA, TABACUM, PERTUSSINUM, TETANUS TOXIN | Deseret Biologicals, Inc. | 4a8deb4a-9f26-46a9-8d99-99df36407f22 | 2024-02-19 | Warnings | ETJ7Z6XBU4 |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | KVK-Tech, Inc. | 7f9c4668-4f4a-453b-b2fa-a6fed903ddfa | 2024-02-16 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | A-S Medication Solutions | f822c103-b678-4e76-8174-33b94421dd1e | 2024-02-15 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Lupin Pharmaceuticals,Inc. | 48cc1378-ffab-4645-95bb-a05d78066575 | 2024-02-15 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.