12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet
- RxCUI
- 1046770
- RxNorm name
- 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet
- Display name
- Hyoscyamine XR (Oral Pill)
- Full name
- 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet
- Term type
- SCD
- Status
- Active
- Strength
- 0.375 mg
- Dose form
- 12 HR XR Tab
- Route
- Oral Pill
- Updated
- 2026-08-03 17:29:10
RxNorm Status History#
- Status
- Active
- Source
- RXNORM
- Current
- YES
- Release start
- 122010
- Active start
- 122010
- Multiple ingredient
- NO
- Branded
- NO
Ingredients And Strength#
| Ingredient | Strength | Base | Basis of strength |
|---|---|---|---|
| hyoscyamine sulfate | 0.375 MG / 1 EACH | hyoscyamine | hyoscyamine sulfate |
Dose Form Concepts#
| Dose form | RxCUI |
|---|---|
| Extended Release Oral Tablet | 316945 |
Derived Ingredient Concepts#
| Ingredient | RxCUI |
|---|---|
| hyoscyamine | 153970 |
Source Vocabulary Codes#
| Code type | Values | Count | Category |
|---|---|---|---|
| PRESCRIBABLE | Y | 1 | ATTRIBUTES |
| RXNAV_STR | 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet | 1 | NAMES |
| RxNorm Name | 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet | 1 | NAMES |
| RxNorm Synonym | 2 | NAMES | |
| TTY | SCD | 1 | ATTRIBUTES |
| SPL_SET_ID | 6 | CODES | |
| RxCUI | 1046770 | 1 | CODES |
| MMSL_CODE | 2 | CODES |
FDA NDC Products And Packages#
| Package NDC | Product NDC | Name | Labeler | Application |
|---|---|---|---|---|
| 16477-738-01 | 16477-738 | Hyoscyamine Sulfate Hyoscyamine Sulfate | Laser Pharmaceuticals, LLC | |
| 39328-052-10 | 39328-052 | Hyoscyamine Sulfate Hyoscyamine Sulfate | Patrin Pharma, Inc. | |
| 51525-0115-1 | 51525-0115 | Hyoscyamine hyoscyamine sulfate | Mylan Pharmaceuticals Inc. | |
| 62135-860-60 | 62135-860 | Hyoscyamine sulfate Hyoscyamine sulfate | Chartwell RX, LLC | |
| 62559-423-01 | 62559-423 | Hyoscyamine Sulfate Hyoscyamine Sulfate | ANI Pharmaceuticals, Inc. | |
| 75929-057-10 | 75929-057 | Hyoscyamine hyoscyamine sulfate | Pharma Packaging Solutions, LLC dba Tjopack 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 |
|---|---|---|---|---|---|---|
| Hyoscyamine Sulfate | HYOSCYAMINE SULFATE | Laser Pharmaceuticals, LLC | b12f856f-7157-4aee-bf73-1fdcb4834ffc | 2025-10-17 | Warnings, Adverse reactions | 16477-738-01 16477-738 16477073801 1046770 |
| Hyoscyamine Sulfate | HYOSCYAMINE SULFATE | ANI Pharmaceuticals, Inc. | 3859133e-88bd-4dd5-90a0-82b64347f1db | 2025-09-12 | Warnings, Adverse reactions | 62559-423-01 62559-423 62559042301 1046770 |
| Levbid | HYOSCYAMINE SULFATE | Viatris Specialty LLC | eb13c96f-319a-46f4-9955-ef5fa0a5f110 | 2025-07-15 | Warnings, Adverse reactions | 1046770 |
| Hyoscyamine Sulfate | HYOSCYAMINE SULFATE | Patrin Pharma, Inc. | d7189f97-d570-4662-8f1d-cf1da02f01ec | 2024-09-03 | Warnings, Adverse reactions | 39328-052-10 39328-052 39328005210 1046770 |
| Hyoscyamine sulfate | HYOSCYAMINE SULFATE | Chartwell RX, LLC | 342edf8e-cca5-4018-9373-0b2e62bc9f4b | 2024-06-07 | Warnings, Adverse reactions | 62135-860-60 62135-860 62135086060 1046770 |
| Hyoscyamine ER | HYOSCYAMINE SULFATE | Mylan Pharmaceuticals Inc. | 5bbce8c0-a9c9-45b9-8457-1542bd3d9449 | 2023-07-15 | Warnings, Adverse reactions | 51525-0115-1 51525-0115 51525011501 1046770 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| eb13c96f-319a-46f4-9955-ef5fa0a5f110 | hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet [SCD] · hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral Tablet [SY] · hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral Tablet [SY] | 4 | 6 | Levbid ® (hyoscyamine sulfate, 0.375 mg) extended-release tablets Rx Only 201090-01 115 Rev. 07/2025 | 20250715 |
| 5bbce8c0-a9c9-45b9-8457-1542bd3d9449 | hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet [SCD] · hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral Tablet [SY] · hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral Tablet [SY] | 4 | 4 | Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg Rx only | 20230715 |
| 01f97804-a6cb-ce6d-e063-6394a90ae220 | hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet [SCD] · hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral Tablet [SY] · hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral Tablet [SY] | 4 | 3 | Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg Rx only (Packaged by Pharma Packaging Solutions, LLC dba Tjoapack LLC) | 20250506 |
| b12f856f-7157-4aee-bf73-1fdcb4834ffc | hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet [SCD] · hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral Tablet [SY] · hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral Tablet [SY] | 4 | 2 | Hyoscyamine Sulfate Tablets 0.375 mg Rx Only | 20251017 |
| 3859133e-88bd-4dd5-90a0-82b64347f1db | hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet [SCD] · hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral Tablet [SY] · hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral Tablet [SY] | 4 | 2 | Hyoscyamine Sulfate Extended-Release Tablets | 20250912 |
| 2bf8d44e-e1b2-4a1d-9914-00bb7ef1293e | hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet [SCD] · hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral Tablet [SY] · hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral Tablet [SY] | 4 | 2 | Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg PI-9328 | 20100217 |
| d7189f97-d570-4662-8f1d-cf1da02f01ec | hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet [SCD] · hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral Tablet [SY] · hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral Tablet [SY] | 4 | 1 | Hyoscyamine Sulfate Extended-Release Oral Tablets, 0.375 mg | 20240903 |
| 342edf8e-cca5-4018-9373-0b2e62bc9f4b | hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet [SCD] · hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral Tablet [SY] · hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral Tablet [SY] | 4 | 1 | Hyoscyamine Sulfate Extended-Release Tablets Rx Only | 20240607 |
| 4c2b85b3-0f7a-4832-9d53-bc026116a1e6 | hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet [SCD] · hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral Tablet [SY] · hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral Tablet [SY] | 4 | 1 | Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg PI-9328 | 20140105 |
Recently Linked DailyMed Labels#
| Set ID | Title | Manufacturer | Effective |
|---|---|---|---|
| b12f856f-7157-4aee-bf73-1fdcb4834ffc | Hyoscyamine Sulfate Tablets 0.375 mg Rx Only | Laser Pharmaceuticals, LLC | 20251017 |
| 3859133e-88bd-4dd5-90a0-82b64347f1db | Hyoscyamine Sulfate Extended-Release Tablets | ANI Pharmaceuticals, Inc. | 20250912 |
| eb13c96f-319a-46f4-9955-ef5fa0a5f110 | Levbid ® (hyoscyamine sulfate, 0.375 mg) extended-release tablets Rx Only 201090-01 115 Rev. 07/2025 | Viatris Specialty LLC | 20250715 |
| 01f97804-a6cb-ce6d-e063-6394a90ae220 | Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg Rx only (Packaged by Pharma Packaging Solutions, LLC dba Tjoapack LLC) | Pharma Packaging Solutions, LLC dba Tjopack LLC | Sovereign Pharmaceuticals, LLC | Pharma Packaging Solutions, LLC dba Tjoapack LLC | 20250506 |
| d7189f97-d570-4662-8f1d-cf1da02f01ec | Hyoscyamine Sulfate Extended-Release Oral Tablets, 0.375 mg | Patrin Pharma, Inc. | 20240903 |
| 342edf8e-cca5-4018-9373-0b2e62bc9f4b | Hyoscyamine Sulfate Extended-Release Tablets Rx Only | Chartwell RX, LLC | Chartwell Pharmaceuticals Congers, LLC | 20240607 |
| d02d1b0d-5c40-c5aa-b283-74efd7d1e06b | Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg | Alvogen Inc. | 20240509 |
| b12f856f-7157-4aee-bf73-1fdcb4834ffc | Hyoscyamine Sulfate Tablets 0.375 mg Rx Only | Laser Pharmaceuticals, LLC | 20240129 |
| d1bb2ea1-cde8-4f3b-93b6-04c7a441f453 | Symax ® -SR | Capellon Pharmaceuticals, LLC | 20230822 |
| 0cab4421-d99e-4cd0-8993-e46c484dc3cb | Symax ® Duotab Hyoscyamine Sulfate BIPHASIC TABLETS* Rx Only *U.S. Patent No. 9,308,164 | Capellon Pharmaceuticals, LLC | 20230821 |
| 5bbce8c0-a9c9-45b9-8457-1542bd3d9449 | Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg Rx only | Mylan Pharmaceuticals Inc. | 20230715 |
| d2b55db1-be5f-4fe0-b31d-21bbe85a34f1 | Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg PI-9328 | County Line Pharmaceuticals, LLC | 20220915 |
| 5361160c-c979-4a4f-8a46-fcf85560c967 | OSCIMIN SR Tablets | Larken Laboratories, Inc. | 20211018 |
| 7344cb82-1d5a-43ff-860a-21d5aac008e2 | Hyoscyamine Sulfate Sustained Release Tablets | KMR Pharmaceuticals LLC | 20150727 |
| 4c2b85b3-0f7a-4832-9d53-bc026116a1e6 | Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg PI-9328 | Aidarex Pharmaceuticals LLC | 20140105 |
| 6e69aa1e-468b-445e-96e9-7334de7ae29a | National Council for Prescription Drug Programs | 20130213 | |
| c89737d4-383c-4c44-8c24-dd5dea8cfb86 | National Council for Prescription Drug Programs | 20130213 | |
| d0d4807b-a0da-4345-8538-23b9851807b8 | National Council for Prescription Drug Programs | 20120724 | |
| eb60f1b7-f6dc-4959-9617-7f7ef5eecde6 | National Council for Prescription Drug Programs | 20120724 | |
| b2aeef34-7f7d-43e4-a7d5-b294d880c279 | National Council for Prescription Drug Programs | 20120724 | |
| a44f0c7a-69fc-440e-94bf-4b992df5b15c | National Council for Prescription Drug Programs | 20120724 | |
| 81592484-e838-4021-bed3-336b573f4066 | National Council for Prescription Drug Programs | 20120724 | |
| 69165d39-1d76-4706-9e35-3cd37a4d2fd9 | National Council for Prescription Drug Programs | 20120724 | |
| 352e6855-b146-4a20-a06e-77e5efc51dff | National Council for Prescription Drug Programs | 20120724 | |
| 3a200492-c460-4b19-ac16-b64493904b88 | Hyoscyamine Sulfate Extended-Release Tablets, USP 0.375 mg | Franklin Pharmaceutical LLC | Sovereign Pharmaceuticals Ltd | Carton Services Inc | 20100408 |
| 2bf8d44e-e1b2-4a1d-9914-00bb7ef1293e | Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg PI-9328 | Carilion Materials Management | 20100217 |
Drug Classes#
| Source | Class ID | Class | Type | Relationship | Drug concept |
|---|---|---|---|---|---|
| ATC | A03BA | Belladonna alkaloids, tertiary amines | ATC1-4 | hyoscyamine | |
| MEDRT | D064692 | Hyoscyamine | CHEM | has_ingredient | hyoscyamine sulfate |
| MEDRT | D064692 | Hyoscyamine | CHEM | has_ingredient | hyoscyamine |
| MEDRT | D000014 | Abnormalities, Drug-Induced | DISEASE | may_treat | hyoscyamine sulfate |
| MEDRT | D000014 | Abnormalities, Drug-Induced | DISEASE | may_treat | hyoscyamine |
| MEDRT | D003085 | Colic | DISEASE | may_treat | hyoscyamine |
| MEDRT | D003085 | Colic | DISEASE | may_treat | hyoscyamine sulfate |
| MEDRT | D003093 | Colitis, Ulcerative | DISEASE | ci_with | hyoscyamine |
| MEDRT | D003093 | Colitis, Ulcerative | DISEASE | ci_with | hyoscyamine sulfate |
| MEDRT | D004342 | Drug Hypersensitivity | DISEASE | ci_with | hyoscyamine |
| MEDRT | D004342 | Drug Hypersensitivity | DISEASE | ci_with | hyoscyamine sulfate |
| MEDRT | D018589 | Gastroparesis | DISEASE | induces | hyoscyamine |
| MEDRT | D018589 | Gastroparesis | DISEASE | induces | hyoscyamine sulfate |
| MEDRT | D005901 | Glaucoma | DISEASE | ci_with | hyoscyamine sulfate |
| MEDRT | D005901 | Glaucoma | DISEASE | ci_with | hyoscyamine |
| MEDRT | D006945 | Hyperhidrosis | DISEASE | may_treat | hyoscyamine sulfate |
| MEDRT | D006945 | Hyperhidrosis | DISEASE | may_treat | hyoscyamine |
| MEDRT | D007077 | Ileal Diseases | DISEASE | ci_with | hyoscyamine |
| MEDRT | D007077 | Ileal Diseases | DISEASE | ci_with | hyoscyamine sulfate |
| MEDRT | D007415 | Intestinal Obstruction | DISEASE | ci_with | hyoscyamine |
| MEDRT | D007415 | Intestinal Obstruction | DISEASE | ci_with | hyoscyamine sulfate |
| MEDRT | D007431 | Intraoperative Complications | DISEASE | may_treat | hyoscyamine |
| MEDRT | D007431 | Intraoperative Complications | DISEASE | may_treat | hyoscyamine sulfate |
| MEDRT | D043183 | Irritable Bowel Syndrome | DISEASE | may_treat | hyoscyamine sulfate |
| MEDRT | D043183 | Irritable Bowel Syndrome | DISEASE | may_treat | hyoscyamine |
| MEDRT | D008532 | Megacolon, Toxic | DISEASE | ci_with | hyoscyamine |
| MEDRT | D008532 | Megacolon, Toxic | DISEASE | ci_with | hyoscyamine sulfate |
| MEDRT | D009127 | Muscle Rigidity | DISEASE | may_treat | hyoscyamine |
| MEDRT | D009127 | Muscle Rigidity | DISEASE | may_treat | hyoscyamine sulfate |
| MEDRT | D009157 | Myasthenia Gravis | DISEASE | ci_with | hyoscyamine sulfate |
| MEDRT | D009157 | Myasthenia Gravis | DISEASE | ci_with | hyoscyamine |
| MEDRT | D017202 | Myocardial Ischemia | DISEASE | ci_with | hyoscyamine |
| MEDRT | D017202 | Myocardial Ischemia | DISEASE | ci_with | hyoscyamine sulfate |
| MEDRT | D010437 | Peptic Ulcer | DISEASE | may_treat | hyoscyamine |
| MEDRT | D010437 | Peptic Ulcer | DISEASE | may_treat | hyoscyamine sulfate |
| MEDRT | D012220 | Rhinitis | DISEASE | may_treat | hyoscyamine |
| MEDRT | D012220 | Rhinitis | DISEASE | may_treat | hyoscyamine sulfate |
| MEDRT | D012771 | Shock, Hemorrhagic | DISEASE | ci_with | hyoscyamine sulfate |
| MEDRT | D012771 | Shock, Hemorrhagic | DISEASE | ci_with | hyoscyamine |
| MEDRT | D012798 | Sialorrhea | DISEASE | may_treat | hyoscyamine sulfate |
| MEDRT | D012798 | Sialorrhea | DISEASE | may_treat | hyoscyamine |
| MEDRT | D013035 | Spasm | DISEASE | may_treat | hyoscyamine |
| MEDRT | D013035 | Spasm | DISEASE | may_treat | hyoscyamine sulfate |
| MEDRT | D014202 | Tremor | DISEASE | may_treat | hyoscyamine |
| MEDRT | D014202 | Tremor | DISEASE | may_treat | hyoscyamine sulfate |
| MEDRT | D014524 | Urethral Obstruction | DISEASE | ci_with | hyoscyamine |
| MEDRT | D014524 | Urethral Obstruction | DISEASE | ci_with | hyoscyamine sulfate |
| MEDRT | D001750 | Urinary Bladder, Neurogenic | DISEASE | may_treat | hyoscyamine sulfate |
| MEDRT | D001750 | Urinary Bladder, Neurogenic | DISEASE | may_treat | hyoscyamine |
| MEDRT | D014987 | Xerostomia | DISEASE | induces | hyoscyamine |
| MEDRT | D014987 | Xerostomia | DISEASE | induces | hyoscyamine sulfate |
| MEDRT | N0000000125 | Cholinergic Muscarinic Antagonists | MOA | has_moa | hyoscyamine sulfate |
| MEDRT | N0000000125 | Cholinergic Muscarinic Antagonists | MOA | has_moa | hyoscyamine |
| MEDRT | N0000000207 | Histamine Receptor Antagonists | MOA | has_moa | hyoscyamine sulfate |
| MEDRT | N0000000207 | Histamine Receptor Antagonists | MOA | has_moa | hyoscyamine |
| MEDRT | N0000000130 | Serotonin Antagonists | MOA | has_moa | hyoscyamine sulfate |
| MEDRT | N0000000130 | Serotonin Antagonists | MOA | has_moa | hyoscyamine |
| MEDRT | N0000008331 | Cardiovascular Activity Alteration | PE | has_pe | hyoscyamine sulfate |
| MEDRT | N0000008331 | Cardiovascular Activity Alteration | PE | has_pe | hyoscyamine |
| MEDRT | N0000008868 | Decreased Respiratory Secretions | PE | has_pe | hyoscyamine sulfate |
| MEDRT | N0000008868 | Decreased Respiratory Secretions | PE | has_pe | hyoscyamine |
Properties#
| Category | Property | Value |
|---|---|---|
| ATTRIBUTES | AVAILABLE_STRENGTH | 0.375 MG |
| ATTRIBUTES | GENERAL_CARDINALITY | SINGLE |
| ATTRIBUTES | HUMAN_DRUG | US |
| ATTRIBUTES | QUANTITY | 12 HR |
| ATTRIBUTES | RXNAV_HUMAN_DRUG | US |
| ATTRIBUTES | SCHEDULE | 0 |
| CODES | VUID | 4006721 |
| NAMES | Prescribable Synonym | hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral Tablet |
| 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 |