Dicyclomine
- Product NDC
- 10544-597
- 11-digit product format
- 105440597
- Labeler code
- 10544
- Product ID
- 10544-597_fbeea6f8-f60a-494c-8bdf-093e48be509e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA040161
- Marketing category
- ANDA
- Marketing start
- 2011-04-01
- Marketing end
- 0000-00-00
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 20 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-597-30 | Dicyclomine | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DICYCLOMINE HYDROCHLORIDE | ACTIVE INGREDIENT | CQ903KQA31 | DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| DICYCLOMINE | ACTIVE MOIETY | 4KV4X8IF6V | DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-597 | DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 1 package rows | 20110608_d70e3238-cb91-44eb-8598-f8713b89be97.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-597-30 | 10544059730 | 30 in 1 BOTTLE | Historical |