Dicyclomine Hydrochloride
- Product NDC
- 10544-560
- 11-digit product format
- 105440560
- Labeler code
- 10544
- Product ID
- 10544-560_0fecc9b6-076c-148b-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA040230
- Marketing category
- ANDA
- Marketing start
- 2013-11-13
- 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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 10544-560-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-0313-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950 |
| 10544-560-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-0313-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-560-30 | Dicyclomine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 10544-560-90 | Dicyclomine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DICYCLOMINE HYDROCHLORIDE | ACTIVE INGREDIENT | CQ903KQA31 | DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| DICYCLOMINE | ACTIVE MOIETY | 4KV4X8IF6V | DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 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 |
|---|
| 10544-560 | DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 2 package rows | 20150225_0fecc9b6-076b-148b-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-560-30 | 10544056030 | 30 in 1 BOTTLE | Historical |
| 10544-560-90 | 10544056090 | 90 in 1 BOTTLE | Historical |