Dicyclomine
- Product NDC
- 21695-218
- 11-digit product format
- 216950218
- Labeler code
- 21695
- Product ID
- 21695-218_1971dce3-875a-43e7-aafc-528600da92b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- Application
- ANDA040204
- Marketing category
- ANDA
- Marketing start
- 1997-02-28
- Marketing end
- 0000-00-00
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Anticholinergic [EPC],Cholinergic Antagonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-218-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4b78-48b1-e053-8cdaa90a720a | Dicyclomine Hydrochloride |
| 21695-218-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4b78-48b1-e053-8cdaa90a720a | Dicyclomine Hydrochloride |
| 21695-218-90 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4b78-48b1-e053-8cdaa90a720a | Dicyclomine Hydrochloride |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-218-30 | Dicyclomine | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | 1 | |
| 21695-218-60 | Dicyclomine | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | 1 | |
| 21695-218-90 | Dicyclomine | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-218-30 | EA - Each | 21695-218 | 265051e4-a180-4791-b8bc-76b90385b22c | 1 | 2012-07-24 |
| 21695-218-60 | EA - Each | 21695-218 | 34078a8f-4ae3-4bc5-8920-7bc74616d434 | 1 | 2012-07-24 |
| 21695-218-90 | EA - Each | 21695-218 | ead66078-2cc5-44ac-8854-7abe8e2ca886 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| DICYCLOMINE HYDROCHLORIDE | ACTIVE INGREDIENT | CQ903KQA31 | DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 | |
| DICYCLOMINE | ACTIVE MOIETY | 4KV4X8IF6V | DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 | |
| Lactose Monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 | |
| Starch, Corn | INACTIVE INGREDIENT | O8232NY3SJ | DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 991061 | dicyclomine HCl 10 MG Oral Capsule | PSN | da10031f-9da8-49a2-a019-5ce80c4b7ede | 1 |
| 991061 | dicyclomine hydrochloride 10 MG Oral Capsule | SCD | da10031f-9da8-49a2-a019-5ce80c4b7ede | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-218-30 | 21695021830 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 21695-218-60 | 21695021860 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 21695-218-90 | 21695021890 | 90 in 1 BOTTLE, PLASTIC | Historical |