Doxycycline
- Product NDC
- 0527-1338
- 11-digit product format
- 005271338
- Labeler code
- 0527
- Product ID
- 0527-1338_dc960a6c-1b09-4049-a1e9-0109576b1d30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxycycline
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA065285
- Marketing category
- ANDA
- Marketing start
- 2005-12-08
- Substance
- DOXYCYCLINE
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXYCYCLINE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N12000U13O |
| Rxcui | 1649429, 1650142, 1650444, 1652673 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0527-1338-25 | Doxycycline | 250 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 250 | | 28 |
| 0527-1338-50 | Doxycycline | 50 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 50 | | 28 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DOXYCYCLINE | ACTIVE INGREDIENT | N12000U13O | DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 14 | |
| DOXYCYCLINE ANHYDROUS | ACTIVE MOIETY | 334895S862 | DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 14 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 14 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 14 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 14 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 14 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 14 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 14 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 14 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 14 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 14 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 14 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 14 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 14 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-1338 | DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 28 | Current NDC, Legacy NDC, 2 package rows | 20240704_4999bbd9-44ed-4749-9730-be2337bdf490.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0527-1338-25 | 00527133825 | 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1338-25) | 2005-12-08 | 0000-00-00 | No | No | Current |
| 0527-1338-50 | 00527133850 | 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1338-50) | 2005-12-08 | 0000-00-00 | No | No | Current |