Dicyclomine Hydrochloride
- Product NDC
- 0378-1610
- 11-digit product format
- 003781610
- Labeler code
- 0378
- Product ID
- 0378-1610_418409e4-d98c-413c-9dba-08925faa334b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dicyclomine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA040319
- Marketing category
- ANDA
- Marketing start
- 1999-11-03
- Marketing end
- 2023-06-30
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f755a917-03bc-45af-a1e3-50286868bfdb | Product name | 9 | 20250303 |
| f27796e1-d653-495b-932a-f51768e9be8a | Product name | 2 | 20211021 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-1610-01 | EA - Each | 0378-1610 | 18245d66-89db-436e-b4db-7e20aff69d34 | 1 | 2012-07-24 |
| 0378-1610-05 | EA - Each | 0378-1610 | a013c34f-3369-42f6-afea-e1edd75f9a62 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 991061 | dicyclomine HCl 10 MG Oral Capsule | PSN | dac1bf89-575b-442e-99ff-6f94da4d872e | 15 |
| 991086 | dicyclomine HCl 20 MG Oral Tablet | PSN | dac1bf89-575b-442e-99ff-6f94da4d872e | 15 |
| 991061 | dicyclomine hydrochloride 10 MG Oral Capsule | SCD | dac1bf89-575b-442e-99ff-6f94da4d872e | 15 |
| 991086 | dicyclomine hydrochloride 20 MG Oral Tablet | SCD | dac1bf89-575b-442e-99ff-6f94da4d872e | 15 |
| 991061 | dicyclomine HCl 10 MG Oral Capsule | PSN | d0f831a3-5b2f-4e39-af9b-01e2e3c497b3 | 2 |
| 991616 | dicyclomine HCl 10 MG Oral Tablet | PSN | b65264c5-2d4a-4290-a084-ddd533e9e954 | 2 |
| 991061 | dicyclomine hydrochloride 10 MG Oral Capsule | SCD | d0f831a3-5b2f-4e39-af9b-01e2e3c497b3 | 2 |
| 991616 | dicyclomine hydrochloride 10 MG Oral Tablet | SCD | b65264c5-2d4a-4290-a084-ddd533e9e954 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0378-1610-01 | 00378161001 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1610-01) | 100 capsule | 1999-11-03 | 2023-06-30 | No | No | Current |
| 0378-1610-05 | 00378161005 | 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-1610-05) | 500 capsule | 1999-11-03 | 2023-06-30 | No | No | Current |