Diltiazem Hydrochloride
- Product NDC
- 0093-0319
- 11-digit product format
- 000930319
- Labeler code
- 0093
- Product ID
- 0093-0319_eb4d8470-1f38-42c6-a511-8383066ed454
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA074185
- Marketing category
- ANDA
- Marketing start
- 1995-12-22
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diltiazem Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DILTIAZEM HYDROCHLORIDE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OLH94387TE |
| Rxcui | 831054, 831102, 831103, 833217 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-0319-01 | Diltiazem Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 14 |
| 0093-0319-05 | Diltiazem Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DILTIAZEM HYDROCHLORIDE | ACTIVE INGREDIENT | OLH94387TE | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| DILTIAZEM | ACTIVE MOIETY | EE92BBP03H | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| POVIDONE K90 | INACTIVE INGREDIENT | RDH86HJV5Z | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| DILTIAZEM HYDROCHLORIDE | ACTIVE INGREDIENT | OLH94387TE | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| DILTIAZEM | ACTIVE MOIETY | EE92BBP03H | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-0319 | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20210429_69ca7cae-fdf3-413a-900b-95cf6e9e7b63.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0093-0319-01 | 00093031901 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-0319-01) | 1995-12-22 | 0000-00-00 | No | No | Current |
| 0093-0319-05 | 00093031905 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-0319-05) | 1995-12-30 | 0000-00-00 | No | No | Current |