Metronidazole
- Product NDC
- 10544-938
- 11-digit product format
- 105440938
- Labeler code
- 10544
- Product ID
- 10544-938_1bf3b606-e931-5233-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA070044
- Marketing category
- ANDA
- Marketing start
- 2015-07-27
- Marketing end
- 0000-00-00
- Substance
- METRONIDAZOLE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 10544-938-14 | Metronidazole | 14 in 1 BOTTLE, PLASTIC | TABLET | 14 | | 3 |
| 10544-938-30 | Metronidazole | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METRONIDAZOLE | ACTIVE INGREDIENT | 140QMO216E | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| METRONIDAZOLE | ACTIVE MOIETY | 140QMO216E | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-938 | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | Legacy NDC, 2 package rows | 20150728_1bdfb0e3-8397-6a61-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-938-14 | 10544093814 | 14 in 1 BOTTLE, PLASTIC | Historical |
| 10544-938-30 | 10544093830 | 30 in 1 BOTTLE | Historical |