Demeclocycline Hydrochloride
- Product NDC
- 53746-555
- 11-digit product format
- 537460555
- Labeler code
- 53746
- Product ID
- 53746-555_bd37276e-8e9f-48ec-9565-a83a5a4f9aea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Demeclocycline
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA065425
- Marketing category
- ANDA
- Marketing start
- 2022-05-25
- Substance
- DEMECLOCYCLINE HYDROCHLORIDE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Demeclocycline Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEMECLOCYCLINE HYDROCHLORIDE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 29O079NTYT |
| Rxcui | 905341, 905347 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53746-555-48 | Demeclocycline Hydrochloride | 48 in 1 BOTTLE | TABLET | 48 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-555 | DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20230217_539add06-e0a0-401a-b4f6-20776084aa9c.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 |
|---|
| 53746-555-48 | 53746055548 | 48 TABLET in 1 BOTTLE (53746-555-48) | 48 tablet | 2022-05-25 | 0000-00-00 | No | No | Current |