Doxycycline
- Product NDC
- 67457-437
- 11-digit product format
- 674570437
- Labeler code
- 67457
- Product ID
- 67457-437_58f9b611-c70f-4606-acdc-32f1f8f1facb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxycycline
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA091406
- Marketing category
- ANDA
- Marketing start
- 2018-12-20
- Substance
- DOXYCYCLINE HYCLATE
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXYCYCLINE HYCLATE | 100 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19XTS3T51U |
| Rxcui | 310027 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-437-00 | Doxycycline | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 10 |
| 67457-437-10 | Doxycycline | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DOXYCYCLINE HYCLATE | ACTIVE INGREDIENT | 19XTS3T51U | DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ] | 3 | |
| DOXYCYCLINE ANHYDROUS | ACTIVE MOIETY | 334895S862 | DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ] | 3 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-437 | DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250117_878a1cf9-31a9-425b-910d-042ed91e98d5.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 |
|---|
| 67457-437-00 | 67457043700 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 67457-437-10 | 67457043710 | 10 VIAL in 1 CARTON (67457-437-10) / 10 mL in 1 VIAL (67457-437-00) | 10 vial | 2018-12-20 | 0000-00-00 | No | No | Current |