NDC 54868-4237-7 - 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
- 54868-4237-7
- Package NDCs from labels
- 54868-4237-0, 54868-4237-4, 54868-4237-7
- 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 |
|---|---|---|---|---|---|---|
| Hair-X Hair Loss Relief | CADMIUM SULFATE, GRAPHITE, PHOSPHORIC ACID, SILICON DIOXIDE, SELENIUM, THALLIUM, USTILAGO MAYDIS | Homeocare Laboratories | 00b62179-e03b-4972-902d-3a0c969b59bc | 2018-12-31 | Warnings | ETJ7Z6XBU4 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG | Allegiant Health | 423a8445-964c-4cdb-889a-f391ca5253e7 | 2018-12-31 | Warnings | 362O9ITL9D |
| Cold Multi-Symptom Night-time | ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI | Allegiant Health | 3f020cf2-6011-4216-9b39-0b3dc5f0749c | 2018-12-26 | Warnings | 362O9ITL9D |
| GUNA-SINUS NOSE | ALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR - POTASSIUM CARBONATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA - SUS SCROFA THYMUS - SUS SCROFA URINARY BLADDER - | Guna spa | 36fef678-17c6-4d2a-a0f0-ddb298611f25 | 2018-12-22 | Warnings | ETJ7Z6XBU4 |
| Gastrozen | COFFEA TOSTA, GLYCYRRHIZA, PHYTOLACCA, TARAXACUM, HYDRASTIS, ARSENICUM ALB, GELSEMIUM, MERC SOLUB, NITRICUM AC, NUX VOM, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, BROMIUM, CADMIUM SULPHURICUM, CINCHONA, CONIUM, HYDROGEN, IODIUM, LACHESIS, PULSATILLA, SILICEA, SULPHURICUM AC | Natural Creations, Inc | 98dd756f-6774-47c3-bdfb-deff82fb801d | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| Runny Nose CP | ALLIUM CEPA, CALC CARB, FERRUM PHOS, HEPAR SULPH CALC, LYCOPODIUM, MERC SOLUB, PULSATILLA, SILICEA, SULPHUR | Natural Creations, Inc | 868ec0ad-9344-4f94-b2c1-2abb48479b15 | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| Mold Antigen | ALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCC | Zorex International | ff92e909-b5a7-417f-98a4-551f1576fd1e | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Allegiant Health | b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f | 2018-12-21 | Warnings | 362O9ITL9D |
| Nausea CP | AETHUSA CYNAPIUM, ANTIMON TART, ARSENICUM ALB, CALC CARB, CHAMOMILLA, CINCHONA, COCCUS, CUPRUM MET, FERRUM MET, IPECAC, KREOSOTUM, LYCOPODIUM, PETROLEUM, PULSATILLA, SILICEA, SULPHUR | Natural Creations, Inc | 2746cde1-577b-41d6-9f22-93d8f1a2c235 | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| Hydrate II | BERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUA | Zorex International | e5f53495-3b75-4d7c-89af-23058fb6fd05 | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| Dust Mix Antigen | ANTIMON TART, ARSENICUM ALB, BLATTA OR, BROMIUM, CALC CARB, CIMEX, DROSERA, HEPAR SULPH CALC, ICTODES FOETIDA, LYCOPODIUM, PHOS, PULSATILLA, SILICEA TERRA, TABACUM FUMUS | Natural Creations, Inc | 8dab4b4a-6fa8-4258-adc1-f8c634e2030b | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| ACETAMINOPHEN | ACETAMINOPHEN | TIME CAP LABORATORIES, INC | 2569383a-4a05-4ddb-852e-b37e487ffcde | 2018-12-17 | Warnings | 362O9ITL9D |
| Comfort-Time | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE | Time Cap Labs, Inc | e94a26a2-36e5-4e1e-aea1-24e035c98043 | 2018-12-14 | Warnings | 362O9ITL9D |
| Severe Cold Head Congestion | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Marc Glassman, Inc. | 3a774544-1994-4a93-9da9-06e55b1a83c8 | 2018-12-13 | Warnings | 362O9ITL9D |
| Clear Choice Regular Strength Pain Reliever | ACETAMINOPHEN | Athlete's Needs, Inc. | d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7 | 2018-12-11 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Walgreen Company | a1cec332-5802-4684-8b7f-6cb98da40e8b | 2018-08-15 | Warnings | 362O9ITL9D |
| HA HP | BELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIA | BioActive Nutritional, Inc. | 30f6c191-ce6e-438c-9601-74f5e8b61f96 | 2018-07-06 | Warnings | ETJ7Z6XBU4 |
| Pain Relief PM | ACETAMINOPHEN PM | Velocity Pharma | c1c1de91-6a54-4d91-93a9-b6be6d7c7dfb | 2018-05-14 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Velocity Pharma LLC | bba2ddc5-19e0-4f11-8ff7-7dd7c2d53b50 | 2018-05-14 | Warnings | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Camber Pharmaceuticals, Inc. | 2a49ee34-6f1d-4ed3-8daa-343723d2a2be | 2018-02-20 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.