Ramipril
- Product NDC
- 0054-0109
- 11-digit product format
- 000540109
- Labeler code
- 0054
- Product ID
- 0054-0109_4019e596-dfb9-43a4-b027-a2bdf6d0f5b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramipril
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA077900
- Marketing category
- ANDA
- Marketing start
- 2008-06-18
- Substance
- RAMIPRIL
- Active strength
- 10 mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme 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
- Ramipril
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RAMIPRIL | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L35JN3I7SJ |
| Rxcui | 198188, 198189, 261962, 845488 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0109-25 | Ramipril | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
| 0054-0109-29 | Ramipril | 500 in 1 BOTTLE | CAPSULE | 500 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RAMIPRIL | ACTIVE INGREDIENT | L35JN3I7SJ | RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] | 4 | |
| RAMIPRILAT | ACTIVE MOIETY | 6N5U4QFC3G | RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] | 4 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] | 4 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] | 4 | |
| RAMIPRIL | ACTIVE INGREDIENT | L35JN3I7SJ | RAMIPRIL CAPSULE [DISPENSING SOLUTIONS, INC.] | 1 | |
| RAMIPRIL | ACTIVE INGREDIENT | L35JN3I7SJ | RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| RAMIPRILAT | ACTIVE MOIETY | 6N5U4QFC3G | RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| RAMIPRILAT | ACTIVE MOIETY | 6N5U4QFC3G | RAMIPRIL CAPSULE [DISPENSING SOLUTIONS, INC.] | 1 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | RAMIPRIL CAPSULE [DISPENSING SOLUTIONS, INC.] | 1 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | RAMIPRIL CAPSULE [DISPENSING SOLUTIONS, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | RAMIPRIL CAPSULE [DISPENSING SOLUTIONS, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | RAMIPRIL CAPSULE [DISPENSING SOLUTIONS, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RAMIPRIL CAPSULE [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0109 | RAMIPRIL CAPSULE [HIKMA PHARMACEUTICALS USA INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20220121_7e9e84f7-ff47-463d-bf47-7a9745960aae.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0109-25 | 00054010925 | 100 CAPSULE in 1 BOTTLE (0054-0109-25) | 100 capsule | 2008-06-18 | 0000-00-00 | No | No | Current |
| 0054-0109-29 | 00054010929 | 500 CAPSULE in 1 BOTTLE (0054-0109-29) | 500 capsule | 2008-06-18 | 0000-00-00 | No | No | Current |