acetaminophen 20 MG/ML / hydrocodone bitartrate 0.667 MG/ML Oral Solution
- RxCUI
- 1044427
- RxNorm name
- acetaminophen 20 MG/ML / hydrocodone bitartrate 0.667 MG/ML Oral Solution
- Display name
- Acetaminophen/HYDROcodone (Oral Liquid)
- Full name
- acetaminophen 20 MG/ML / hydrocodone bitartrate 0.667 MG/ML Oral Solution
- Term type
- SCD
- Status
- Active
- Strength
- 300-10 mg/15ml
- Dose form
- Sol
- Route
- Oral Liquid
- Updated
- 2026-08-03 17:28:55
RxNorm Status History#
- Status
- Active
- Source
- RXNORM
- Current
- YES
- Release start
- 122010
- Active start
- 122010
- Multiple ingredient
- YES
- Branded
- NO
Ingredients And Strength#
| Ingredient | Strength | Base | Basis of strength |
|---|---|---|---|
| acetaminophen | 20 MG / 1 ML | acetaminophen | acetaminophen |
| hydrocodone bitartrate | 0.667 MG / 1 ML | hydrocodone | hydrocodone bitartrate |
Dose Form Concepts#
| Dose form | RxCUI |
|---|---|
| Oral Solution | 316968 |
Derived Ingredient Concepts#
| Ingredient | RxCUI |
|---|---|
| acetaminophen | 161 |
| hydrocodone | 5489 |
Source Vocabulary Codes#
| Code type | Values | Count | Category |
|---|---|---|---|
| PRESCRIBABLE | Y | 1 | ATTRIBUTES |
| RXNAV_STR | acetaminophen 20 MG/ML / HYDROcodone bitartrate 0.667 MG/ML Oral Solution | 1 | NAMES |
| RxNorm Name | acetaminophen 20 MG/ML / hydrocodone bitartrate 0.667 MG/ML Oral Solution | 1 | NAMES |
| RxNorm Synonym | 2 | NAMES | |
| TTY | SCD | 1 | ATTRIBUTES |
| SPL_SET_ID | 2 | CODES | |
| RxCUI | 1044427 | 1 | CODES |
| MMSL_CODE | 2 | CODES |
FDA NDC Products And Packages#
| Package NDC | Product NDC | Name | Labeler | Application |
|---|---|---|---|---|
| 0054-0843-63 | 0054-0843 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Hikma Pharmaceuticals USA Inc. | ANDA040881 |
| 27808-130-01 | 27808-130 | hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen | Cranbury Pharmaceuticals, LLC | ANDA201295 |
Drugs@FDA Applications#
| Application | NDC | Name | Marketing category | Labeler |
|---|---|---|---|---|
| ANDA040881 | 0054-0843 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ANDA | Hikma Pharmaceuticals USA Inc. |
| ANDA201295 | 27808-130 | hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen | ANDA | Cranbury Pharmaceuticals, LLC |
UNII Substances#
No records found.
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 |
|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Hikma Pharmaceuticals USA Inc. | 995a6cc7-8b72-4d35-b3b4-8c5752438fb7 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 0054-0843-63 0054-0843 00054084363 1044427 |
| hydrocodone bitartrate and acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Cranbury Pharmaceuticals, LLC | 93b6dfdf-ba6e-4ea6-ab85-5ac121e33101 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 27808-130-01 27808-130 27808013001 1044427 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 93b6dfdf-ba6e-4ea6-ab85-5ac121e33101 | HYDROcodone bitartrate 10 MG / acetaminophen 300 MG in 15 mL Oral Solution [PSN] · acetaminophen 20 MG/ML / hydrocodone bitartrate 0.667 MG/ML Oral Solution [SCD] · APAP 20 MG/ML / Hydrocodone Bitartrate 0.667 MG/ML Oral Solution [SY] · APAP 300 MG / hydrocodone bitartrate 10 MG per 15 ML Oral Solution [SY] | 4 | 23 | Hydrocodone Bitartrate and Acetaminophen Oral Solution (CII) 10 mg/300 mg per 15 mL Rx Only | 20260108 |
| 995a6cc7-8b72-4d35-b3b4-8c5752438fb7 | HYDROcodone bitartrate 10 MG / acetaminophen 300 MG in 15 mL Oral Solution [PSN] · acetaminophen 20 MG/ML / hydrocodone bitartrate 0.667 MG/ML Oral Solution [SCD] · APAP 20 MG/ML / Hydrocodone Bitartrate 0.667 MG/ML Oral Solution [SY] · APAP 300 MG / hydrocodone bitartrate 10 MG per 15 ML Oral Solution [SY] | 4 | 2 | Hydrocodone Bitartrate and Acetaminophen Oral Solution, 10 mg/300 mg per 15 mL | 20250122 |
| 34fddb2d-ccc5-4189-ac2a-146b46c447f6 | HYDROcodone bitartrate 10 MG / acetaminophen 300 MG in 15 mL Oral Solution [PSN] · acetaminophen 20 MG/ML / hydrocodone bitartrate 0.667 MG/ML Oral Solution [SCD] · APAP 20 MG/ML / Hydrocodone Bitartrate 0.667 MG/ML Oral Solution [SY] · APAP 300 MG / hydrocodone bitartrate 10 MG per 15 ML Oral Solution [SY] | 4 | 2 | 20160629 |
Recently Linked DailyMed Labels#
| Set ID | Title | Manufacturer | Effective |
|---|---|---|---|
| 995a6cc7-8b72-4d35-b3b4-8c5752438fb7 | Hydrocodone Bitartrate and Acetaminophen Oral Solution, 10 mg/300 mg per 15 mL | Hikma Pharmaceuticals USA Inc. | 20260728 |
| 995a6cc7-8b72-4d35-b3b4-8c5752438fb7 | Hydrocodone Bitartrate and Acetaminophen Oral Solution, 10 mg/300 mg per 15 mL | Hikma Pharmaceuticals USA Inc. | 20260423 |
| 93b6dfdf-ba6e-4ea6-ab85-5ac121e33101 | Hydrocodone Bitartrate and Acetaminophen Oral Solution (CII) 10 mg/300 mg per 15 mL Rx Only | Cranbury Pharmaceuticals, LLC | 20260108 |
| 995a6cc7-8b72-4d35-b3b4-8c5752438fb7 | Hydrocodone Bitartrate and Acetaminophen Oral Solution, 10 mg/300 mg per 15 mL | Hikma Pharmaceuticals USA Inc. | 20250122 |
| 7da90197-5801-4855-956e-a9373b3dec8c | Hydrocodone Bitartrate and Acetaminophen Oral Solution 10 mg/300 mg per 15 mL | Mikart, LLC | 20201231 |
Drug Classes#
| Source | Class ID | Class | Type | Relationship | Drug concept |
|---|---|---|---|---|---|
| ATC | N02BE | Anilides | ATC1-4 | acetaminophen | |
| ATC | R05DA | Opium alkaloids and derivatives | ATC1-4 | hydrocodone | |
| FDASPL | N0000175690 | Opioid Agonist | EPC | has_epc | hydrocodone |
| FDASPL | N0000000174 | Opioid Agonists | MOA | has_moa | hydrocodone |
| MEDRT | D000082 | Acetaminophen | CHEM | has_ingredient | acetaminophen |
| MEDRT | D006853 | Hydrocodone | CHEM | has_ingredient | hydrocodone bitartrate |
| MEDRT | D006853 | Hydrocodone | CHEM | has_ingredient | hydrocodone |
| MEDRT | D001249 | Asthma | DISEASE | ci_with | hydrocodone bitartrate |
| MEDRT | D001249 | Asthma | DISEASE | ci_with | hydrocodone |
| MEDRT | D003371 | Cough | DISEASE | may_treat | hydrocodone bitartrate |
| MEDRT | D003371 | Cough | DISEASE | may_treat | hydrocodone |
| MEDRT | D004342 | Drug Hypersensitivity | DISEASE | ci_with | hydrocodone bitartrate |
| MEDRT | D004342 | Drug Hypersensitivity | DISEASE | ci_with | hydrocodone |
| MEDRT | D004342 | Drug Hypersensitivity | DISEASE | ci_with | acetaminophen |
| MEDRT | D005334 | Fever | DISEASE | may_prevent | acetaminophen |
| MEDRT | D005334 | Fever | DISEASE | may_treat | acetaminophen |
| MEDRT | D005955 | Glucosephosphate Dehydrogenase Deficiency | DISEASE | ci_with | acetaminophen |
| MEDRT | D007415 | Intestinal Obstruction | DISEASE | ci_with | hydrocodone |
| MEDRT | D007415 | Intestinal Obstruction | DISEASE | ci_with | hydrocodone bitartrate |
| MEDRT | D008107 | Liver Diseases | DISEASE | ci_with | acetaminophen |
| MEDRT | D008173 | Lung Diseases, Obstructive | DISEASE | may_treat | hydrocodone |
| MEDRT | D008173 | Lung Diseases, Obstructive | DISEASE | may_treat | hydrocodone bitartrate |
| MEDRT | D010146 | Pain | DISEASE | may_treat | acetaminophen |
| MEDRT | D010146 | Pain | DISEASE | may_prevent | acetaminophen |
| MEDRT | D010149 | Postoperative Pain | DISEASE | may_treat | hydrocodone |
| MEDRT | D010149 | Postoperative Pain | DISEASE | may_treat | hydrocodone bitartrate |
| MEDRT | D012131 | Respiratory Insufficiency | DISEASE | ci_with | hydrocodone |
| MEDRT | D012131 | Respiratory Insufficiency | DISEASE | ci_with | hydrocodone bitartrate |
| MEDRT | N0000191866 | Opioid mu-Receptor Agonists | MOA | has_moa | hydrocodone bitartrate |
| MEDRT | N0000191866 | Opioid mu-Receptor Agonists | MOA | has_moa | hydrocodone |
| MEDRT | N0000000108 | Prostaglandin Receptor Antagonists | MOA | has_moa | acetaminophen |
| MEDRT | N0000175439 | Analgesia | PE | has_pe | hydrocodone |
| MEDRT | N0000175439 | Analgesia | PE | has_pe | hydrocodone bitartrate |
| MEDRT | N0000175724 | Central Nervous System Activity Alteration | PE | has_pe | acetaminophen |
| MEDRT | N0000008501 | Decreased Central Nervous System Organized Electrical Activity | PE | ci_pe | hydrocodone bitartrate |
| MEDRT | N0000008501 | Decreased Central Nervous System Organized Electrical Activity | PE | ci_pe | hydrocodone |
| MEDRT | N0000008701 | Decreased Medullary Respiratory Drive | PE | has_pe | hydrocodone bitartrate |
| MEDRT | N0000008701 | Decreased Medullary Respiratory Drive | PE | has_pe | hydrocodone |
| MEDRT | N0000008768 | Decreased Organized Electrical Activity | PE | has_pe | hydrocodone |
| MEDRT | N0000008768 | Decreased Organized Electrical Activity | PE | has_pe | hydrocodone bitartrate |
| MEDRT | N0000008836 | Decreased Prostaglandin Production | PE | has_pe | acetaminophen |
| MEDRT | N0000009072 | Hypothalamic Endocrine Activity Alteration | PE | has_pe | acetaminophen |
| MEDRT | N0000175725 | Peripheral Nervous System Activity Alteration | PE | has_pe | acetaminophen |
| MEDRT | N0000000026 | Hepatic Metabolism | PK | has_pk | acetaminophen |
| MEDRT | N0000000042 | Renal Excretion | PK | has_pk | acetaminophen |
Properties#
| Category | Property | Value |
|---|---|---|
| ATTRIBUTES | AVAILABLE_STRENGTH | 20 MG/ML / 0.667 MG/ML |
| ATTRIBUTES | GENERAL_CARDINALITY | MULTI |
| ATTRIBUTES | HUMAN_DRUG | US |
| ATTRIBUTES | RXNAV_HUMAN_DRUG | US |
| ATTRIBUTES | SCHEDULE | 2 |
| CODES | ANDA | ANDA040881 |
| CODES | ANDA | ANDA201295 |
| CODES | VUID | 4032836 |
| CODES | VUID | 4044022 |
| NAMES | Prescribable Synonym | HYDROcodone bitartrate 10 MG / acetaminophen 300 MG in 15 mL Oral Solution |
| NAMES | Tallman Synonym | acetaminophen 20 MG/ML / HYDROcodone bitartrate 0.667 MG/ML Oral Solution |
| NAMES | Tallman Synonym | APAP 20 MG/ML / HYDROcodone Bitartrate 0.667 MG/ML Oral Solution |
| NAMES | Tallman Synonym | APAP 300 MG / HYDROcodone bitartrate 10 MG per 15 ML Oral Solution |
| SOURCES | Source | Gold Standard Alchemy |
| SOURCES | Source | Metathesaurus FDA Structured Product Labels |
| SOURCES | Source | Micromedex RED BOOK |
| SOURCES | Source | Multum MediSource Lexicon |
| SOURCES | Source | National Drug Data File Plus Source Vocabulary |
| SOURCES | Source | Veterans Health Administration National Drug File |