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NDC 64764-0080-40 Amitiza 8 ug/1 Details
Amitiza 8 ug/1
Amitiza is a ORAL CAPSULE, GELATIN COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is LUBIPROSTONE.
MedlinePlus Drug Summary
Lubiprostone is used to relieve stomach pain, bloating, and straining and produce softer and more frequent bowel movements in people who have chronic idiopathic constipation (difficult or infrequent passage of stools that lasts for 3 months or longer and is not caused by a disease or a medication). Lubiprostone is also used to treat irritable bowel syndrome with constipation (IBS-C; a condition that causes stomach pain or cramps, bloating, and infrequent or difficult passage of stools) in women who are at least 18 years of age. Lubiprostone is also used to treat constipation caused by certain opioid (narcotic) pain medications in people with chronic (on-going), noncancer pain. Lubiprostone is in a class of medications called laxatives. It works by increasing the amount of fluid that flows into the bowel and allowing the stool to pass more easily.
Related Packages: 64764-0080-40Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lubiprostone
Product Information
| NDC | 64764-0080 |
|---|---|
| Product ID | 64764-080_7a1ad838-dfa0-4cfa-bca0-d04b1a383102 |
| Associated GPIs | 52450045000110 |
| GCN Sequence Number | 063946 |
| GCN Sequence Number Description | lubiprostone CAPSULE 8 MCG ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 99658 |
| HICL Sequence Number | 033451 |
| HICL Sequence Number Description | LUBIPROSTONE |
| Brand/Generic | Brand |
| Proprietary Name | Amitiza |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | lubiprostone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, GELATIN COATED |
| Route | ORAL |
| Active Ingredient Strength | 8 |
| Active Ingredient Units | ug/1 |
| Substance Name | LUBIPROSTONE |
| Labeler Name | Takeda Pharmaceuticals America, Inc. |
| Pharmaceutical Class | Chloride Channel Activator [EPC], Chloride Channel Activators [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021908 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 64764-0080-40 (64764008040)
| NDC Package Code | 64764-080-40 |
|---|---|
| Billing NDC | 64764008040 |
| Package | 4 CARTON in 1 CARTON (64764-080-40) / 1 BLISTER PACK in 1 CARTON / 4 CAPSULE, GELATIN COATED in 1 BLISTER PACK |
| Marketing Start Date | 2008-04-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |