Loperamide Hydrochloride
- Product NDC
- 50383-618
- 11-digit product format
- 503830618
- Labeler code
- 50383
- Product ID
- 50383-618_b35dcfa7-3a19-48ae-a8c7-dc03249f9134
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Akorn
- Application
- ANDA074352
- Marketing category
- ANDA
- Marketing start
- 1995-11-17
- Marketing end
- 0000-00-00
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 1 mg/5mL
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 10f838ef-a72b-645d-80f8-e2255205c3b1 | Product name | 6 | 20240805 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50383-618-04 | ML - Milliliter | 50383-618 | 8b63b39a-50bc-4955-a19f-2bf658aab638 | 1 | 2012-07-24 |
| 50383-618-05 | ML - Milliliter | 50383-618 | cebec501-71fb-4138-b911-b4abaea5d479 | 1 | 2013-10-17 |
| 50383-618-06 | ML - Milliliter | 50383-618 | 4aff43b9-f08c-42f0-891d-7d579728476b | 1 | 2013-08-02 |
| 50383-618-10 | ML - Milliliter | 50383-618 | 87fa7eba-05a0-4c90-b62a-deeca64cc69a | 1 | 2013-10-17 |
| 50383-618-11 | ML - Milliliter | 50383-618 | fdcbc23c-0d0d-4c51-9133-220296523bcb | 1 | 2013-08-02 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 977986 | loperamide HCl 1 MG in 5 mL Oral Solution | PSN | b0596b9c-326d-4795-b0a5-38c858af7a77 | 5 |
| 977986 | loperamide hydrochloride 0.2 MG/ML Oral Solution | SCD | b0596b9c-326d-4795-b0a5-38c858af7a77 | 5 |
| 977986 | loperamide hydrochloride 1 MG per 5 ML Oral Solution | SY | b0596b9c-326d-4795-b0a5-38c858af7a77 | 5 |
| 977986 | loperamide hydrochloride 2 MG per 10 ML Oral Solution | SY | b0596b9c-326d-4795-b0a5-38c858af7a77 | 5 |
| 977986 | loperamide HCl 1 MG in 5 mL Oral Solution | PSN | 0f7e440d-0d62-402d-856d-e08198c6004f | 3 |
| 977986 | loperamide hydrochloride 0.2 MG/ML Oral Solution | SCD | 0f7e440d-0d62-402d-856d-e08198c6004f | 3 |
| 977986 | loperamide hydrochloride 1 MG per 5 ML Oral Solution | SY | 0f7e440d-0d62-402d-856d-e08198c6004f | 3 |
| 977986 | loperamide hydrochloride 2 MG per 10 ML Oral Solution | SY | 0f7e440d-0d62-402d-856d-e08198c6004f | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50383-618-04 | 50383061804 | 1 BOTTLE in 1 CARTON (50383-618-04) > 118 mL in 1 BOTTLE | 1 bottle | 1995-11-17 | 0000-00-00 | No | No | Current |
| 50383-618-06 | 50383061806 | 4 TRAY in 1 CASE (50383-618-06) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (50383-618-05) | 4 tray | 2015-02-27 | 0000-00-00 | No | No | Current |
| 50383-618-11 | 50383061811 | 4 TRAY in 1 CASE (50383-618-11) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-618-10) | 4 tray | 2015-02-27 | 0000-00-00 | No | No | Current |