doxycycline hyclate
- Product NDC
- 70436-032
- 11-digit product format
- 704360032
- Labeler code
- 70436
- Product ID
- 70436-032_3c36af25-61de-f322-e063-6394a90ab704
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxycycline hyclate
- Dosage form
- POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Slate Run Pharmaceuticals, LLC
- Application
- ANDA217685
- Marketing category
- ANDA
- Marketing start
- 2024-07-22
- Substance
- DOXYCYCLINE ANHYDROUS
- Active strength
- 100 mg/10mL
- Pharmacologic classes
- Tetracycline-class Drug [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
- doxycycline hyclate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXYCYCLINE ANHYDROUS | 100 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 334895S862 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70436-032-35 | doxycycline hyclate | 10 mL in 1 VIAL, SINGLE-DOSE | POWDER, FOR SOLUTION | 10 | | 5 |
| 70436-032-82 | doxycycline hyclate | 10 in 1 CARTON | POWDER, FOR SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70436-032 | DOXYCYCLINE HYCLATE POWDER, FOR SOLUTION [SLATE RUN PHARMACEUTICALS, LLC] | 2 | Current NDC, 2 package rows | 20240722_f31e69fc-e513-40e4-91b5-22ccf1ed9437.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70436-032-35 | 70436003235 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | Historical |
| 70436-032-82 | 70436003282 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-032-82) / 10 mL in 1 VIAL, SINGLE-DOSE (70436-032-35) | | 2024-07-22 | No | No | Current |