Diltiazem Hydrochloride
- Product NDC
- 53808-0695
- 11-digit product format
- 538080695
- Labeler code
- 53808
- Product ID
- 53808-0695_e5e7eb22-fc88-4fc8-a047-1d785435448a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride
- Dosage form
- CAPSULE, COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA074984
- Marketing category
- ANDA
- Marketing start
- 2013-01-01
- Marketing end
- 0000-00-00
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 240 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 53808-0695-2 | Diltiazem HydrochlorideExtended Release | 60 in 1 BLISTER PACK | CAPSULE, COATED, EXTENDED RELEAS | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DILTIAZEM HYDROCHLORIDE | ACTIVE INGREDIENT | OLH94387TE | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| DILTIAZEM | ACTIVE MOIETY | EE92BBP03H | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| AMMONIO METHACRYLATE COPOLYMER TYPE A | INACTIVE INGREDIENT | 8GQS4E66YY | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| AMMONIO METHACRYLATE COPOLYMER TYPE B | INACTIVE INGREDIENT | 161H3B14U2 | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53808-0695 | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20140408_46eb53b9-89d4-4566-8e42-fb7d355eb052.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53808-0695-2 | 53808069502 | 60 in 1 BLISTER PACK | Historical |