Doxycycline Hyclate
- Product NDC
- 43386-794
- 11-digit product format
- 433860794
- Labeler code
- 43386
- Product ID
- 43386-794_21feab96-ff6a-4924-8dcb-becaf40d9356
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxycycline Hyclate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA207558
- Marketing category
- ANDA
- Marketing start
- 2017-09-06
- Substance
- DOXYCYCLINE HYCLATE
- Active strength
- 100 mg/1
- 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 HYCLATE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19XTS3T51U |
| Rxcui | 1650143 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-794-01 | Doxycycline Hyclate | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 43386-794-02 | Doxycycline Hyclate | 20 in 1 BOTTLE | TABLET | 20 | | 4 |
| 43386-794-05 | Doxycycline Hyclate | 500 in 1 BOTTLE | TABLET | 500 | | 4 |
| 43386-794-10 | Doxycycline Hyclate | 1000 in 1 BOTTLE | TABLET | 1000 | | 4 |
| 43386-794-50 | Doxycycline Hyclate | 50 in 1 BOTTLE | TABLET | 50 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-794 | DOXYCYCLINE HYCLATE TABLET [LUPIN PHARMACEUTICALS,INC.] | 4 | Current NDC, Legacy NDC, 5 package rows | 20240131_b752ea66-3144-4f78-96fe-a5f4d92740a7.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 |
|---|
| 43386-794-01 | 43386079401 | 100 TABLET in 1 BOTTLE (43386-794-01) | 100 tablet | 2017-09-06 | 0000-00-00 | No | No | Current |
| 43386-794-02 | 43386079402 | 20 TABLET in 1 BOTTLE (43386-794-02) | 20 tablet | 2017-09-06 | 0000-00-00 | No | No | Current |
| 43386-794-05 | 43386079405 | 500 TABLET in 1 BOTTLE (43386-794-05) | 500 tablet | 2017-09-06 | 0000-00-00 | No | No | Current |
| 43386-794-10 | 43386079410 | 1000 TABLET in 1 BOTTLE (43386-794-10) | 1000 tablet | 2018-02-13 | 0000-00-00 | No | No | Current |
| 43386-794-50 | 43386079450 | 50 TABLET in 1 BOTTLE (43386-794-50) | 50 tablet | 2017-09-06 | 0000-00-00 | No | No | Current |