DOXYCYCLINE
- Product NDC
- 68083-481
- 11-digit product format
- 680830481
- Labeler code
- 68083
- Product ID
- 68083-481_ca2211dc-d46a-4069-8aa3-a146475427a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DOXYCYCLINE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA215583
- Marketing category
- ANDA
- Marketing start
- 2023-04-12
- 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 |
|---|
| 68083-481-10 | DOXYCYCLINE | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 6 |
| 68083-481-10 | DOXYCYCLINE | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-481 | DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] | 6 | Current NDC, 2 package rows | 20250323_6a5780a9-4548-427c-972a-ef49fdcbc84d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-481-10 | 68083048110 | 10 VIAL in 1 CARTON (68083-481-10) / 10 mL in 1 VIAL | 10 vial | 2023-04-12 | No | No | Current |