Metronidazole
- Product NDC
- 54348-745
- 11-digit product format
- 543480745
- Labeler code
- 54348
- Product ID
- 54348-745_eaa5779b-424d-01ba-e053-2a95a90ae500
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METRONIDAZOLE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PharmPak, Inc.
- Application
- ANDA203458
- Marketing category
- ANDA
- Marketing start
- 2019-07-12
- Substance
- METRONIDAZOLE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metronidazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METRONIDAZOLE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 140QMO216E |
| Rxcui | 314106 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54348-745-08 | Metronidazole | 8 in 1 BOTTLE | TABLET, FILM COATED | 8 | | 2 |
| 54348-745-08 | Metronidazole | 1 in 1 BOX | TABLET, FILM COATED | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54348-745 | METRONIDAZOLE TABLET, FILM COATED [PHARMPAK, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221011_6a77b5b6-3199-4526-bd68-2e511353d7c6.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 |
|---|
| 54348-745-08 | 54348074508 | 1 BOTTLE in 1 BOX (54348-745-08) / 8 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2019-07-12 | 0000-00-00 | No | No | Current |