Nimodipine
- Product NDC
- 68084-912
- 11-digit product format
- 680840912
- Labeler code
- 68084
- Product ID
- 68084-912_f05be1cf-fc2d-9bf2-e053-2a95a90ac12c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nimodipine
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA090103
- Marketing category
- ANDA
- Marketing start
- 2015-02-17
- Marketing end
- 2023-09-30
- Substance
- NIMODIPINE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 68084-912 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 68084-912 | 68084-912-31 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 68084-912 | 68084-912-32 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A090103-001 | NIMODIPINE | NIMODIPINE | 30MG | CAPSULE / ORAL | AB | | 2014-04-07 |
Therapeutic equivalence codes#
Application-product, TE code table| Application-product | TE code |
|---|
| A090103-001 | AB |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NIMODIPINE | ACTIVE INGREDIENT | 57WA9QZ5WH | NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 2 | |
| NIMODIPINE | ACTIVE MOIETY | 57WA9QZ5WH | NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 2 | |
| PEPPERMINT OIL | INACTIVE INGREDIENT | AV092KU4JH | NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 2 | |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68084-912-31 | 68084091231 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-912-31) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68084-912-33) | 100 blister pack | 2015-10-30 | 0000-00-00 | No | No | Current |
| 68084-912-32 | 68084091232 | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-912-32) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68084-912-33) | 20 blister pack | 2015-02-17 | 0000-00-00 | No | No | Current |