Doxycycline
- Product NDC
- 43386-791
- 11-digit product format
- 433860791
- Labeler code
- 43386
- Product ID
- 43386-791_a3ed2ee4-163c-4167-abf2-59a7e1d66a61
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxycycline
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA204446
- Marketing category
- ANDA
- Marketing start
- 2015-07-08
- Substance
- DOXYCYCLINE
- Active strength
- 75 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXYCYCLINE | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N12000U13O |
| Rxcui | 700408, 1649401, 1649990 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-791-01 | Doxycycline | 100 in 1 BOTTLE | CAPSULE | 100 | | 4 |
| 43386-791-10 | Doxycycline | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 4 |
| 43386-791-11 | Doxycycline | 50 in 1 BOTTLE | CAPSULE | 50 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DOXYCYCLINE | ACTIVE INGREDIENT | N12000U13O | DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| DOXYCYCLINE ANHYDROUS | ACTIVE MOIETY | 334895S862 | DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-791 | DOXYCYCLINE CAPSULE [LUPIN PHARMACEUTICALS,INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20240131_6512bf22-c211-4127-a8c8-2419656580f6.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 |
|---|
| 43386-791-01 | 43386079101 | 100 CAPSULE in 1 BOTTLE (43386-791-01) | 100 capsule | 2015-07-08 | 0000-00-00 | No | No | Current |
| 43386-791-10 | 43386079110 | 1000 CAPSULE in 1 BOTTLE (43386-791-10) | 1000 capsule | 2015-07-08 | 0000-00-00 | No | No | Current |
| 43386-791-11 | 43386079111 | 50 CAPSULE in 1 BOTTLE (43386-791-11) | 50 capsule | 2015-07-08 | 0000-00-00 | No | No | Current |