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NDC 43386-0540-01 Morphine Sulfate 15 mg/1 Details
Morphine Sulfate 15 mg/1
Morphine Sulfate is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals,Inc.. The primary component is MORPHINE SULFATE.
MedlinePlus Drug Summary
Morphine is used to relieve moderate to severe pain. Morphine extended-release tablets and capsules are only used to relieve severe (around-the-clock) pain that cannot be controlled by the use of other pain medications. Morphine extended-release tablets and capsules should not be used to treat pain that can be controlled by medication that is taken as needed. Morphine is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
Related Packages: 43386-0540-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Morphine
Product Information
| NDC | 43386-0540 |
|---|---|
| Product ID | 43386-540_ac0a5db2-f086-4e60-9fca-537796ea535d |
| Associated GPIs | 65100055100415 |
| GCN Sequence Number | 011887 |
| GCN Sequence Number Description | morphine sulfate TABLET ER 15 MG ORAL |
| HIC3 | H3A |
| HIC3 Description | OPIOID ANALGESICS |
| GCN | 16643 |
| HICL Sequence Number | 001694 |
| HICL Sequence Number Description | MORPHINE SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | Morphine Sulfate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Morphine Sulfate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 15 |
| Active Ingredient Units | mg/1 |
| Substance Name | MORPHINE SULFATE |
| Labeler Name | Lupin Pharmaceuticals,Inc. |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA203602 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43386-0540-01 (43386054001)
| NDC Package Code | 43386-540-01 |
|---|---|
| Billing NDC | 43386054001 |
| Package | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43386-540-01) |
| Marketing Start Date | 2015-12-16 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.19105 |
| Pricing Unit | EA |
| Effective Date | 2022-03-23 |
| NDC Description | MORPHINE SULF ER 15 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2022-04-06 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
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