Dicyclomine Hydrochloride
- Product NDC
- 0440-7384
- 11-digit product format
- 004407384
- Labeler code
- 0440
- Product ID
- 0440-7384_6a458cdc-7859-4a91-bb5f-25e7bd91da7a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Liberty Pharmaceuticals, Inc.
- Application
- ANDA084285
- Marketing category
- ANDA
- Marketing start
- 1974-09-30
- 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
- 2018-12-31
- 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 |
|---|
| 0440-7384-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-76a5-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 |
| 0440-7384-06 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-76a5-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 |
| 0440-7384-12 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-76a5-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 |
|---|
| 0440-7384-04 | Dicyclomine Hydrochloride | 4 in 1 BOTTLE, PLASTIC | CAPSULE | 4 | | 1 |
| 0440-7384-06 | Dicyclomine Hydrochloride | 6 in 1 BOTTLE, PLASTIC | CAPSULE | 6 | | 1 |
| 0440-7384-12 | Dicyclomine Hydrochloride | 12 in 1 BOTTLE, PLASTIC | CAPSULE | 12 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DICYCLOMINE HYDROCHLORIDE | ACTIVE INGREDIENT | CQ903KQA31 | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| DICYCLOMINE | ACTIVE MOIETY | 4KV4X8IF6V | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| CALCIUM SULFATE | INACTIVE INGREDIENT | WAT0DDB505 | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0440-7384 | DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 3 package rows | 20140211_59b4c00d-74cd-44a6-a76c-d44e93bbeca9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 0440-7384-04 | 00440738404 | 4 in 1 BOTTLE, PLASTIC | Historical |
| 0440-7384-06 | 00440738406 | 6 in 1 BOTTLE, PLASTIC | Historical |
| 0440-7384-12 | 00440738412 | 12 in 1 BOTTLE, PLASTIC | Historical |