Loperamide Hydrochloride
- Product NDC
- 68151-0618
- 11-digit product format
- 681510618
- Labeler code
- 68151
- Product ID
- 68151-0618_4f6b4550-c33c-45ef-8b6d-ea950337bf52
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Carilion Materials Management
- Application
- ANDA074352
- Marketing category
- ANDA
- Marketing start
- 1995-11-17
- Marketing end
- 0000-00-00
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 1 mg/5mL
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68151-0618-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1ee1-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-0618-1 | Loperamide Hydrochloride | 1 mL in 1 SYRINGE, PLASTIC | SOLUTION | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-0618 | LOPERAMIDE HYDROCHLORIDE SOLUTION [CARILION MATERIALS MANAGEMENT] | 3 | Legacy NDC, 1 package rows | 20171229_0f7e440d-0d62-402d-856d-e08198c6004f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 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 | Status |
|---|---|---|---|---|
| 68151-0618-1 | 68151061801 | 1 mL in 1 SYRINGE, PLASTIC | 1 ml | Historical |