Doxycycline
- Product NDC
- 63304-131
- 11-digit product format
- 633040131
- Labeler code
- 63304
- Product ID
- 63304-131_fd417a50-69b5-40b4-89fd-58aea77ab547
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxycycline
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries Inc.
- Application
- ANDA065356
- Marketing category
- ANDA
- Marketing start
- 2018-08-06
- 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 | 1649429, 1650142, 1650444, 1652673 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63304-131-01 | Doxycycline | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 5 |
| 63304-131-10 | Doxycycline | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DOXYCYCLINE | ACTIVE INGREDIENT | N12000U13O | DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 3 | |
| DOXYCYCLINE ANHYDROUS | ACTIVE MOIETY | 334895S862 | DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 3 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-131 | DOXYCYCLINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20180807_8224b9c5-5c4b-4dda-bc58-47b6604c2884.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 |
|---|
| 63304-131-01 | 63304013101 | 100 TABLET, FILM COATED in 1 BOTTLE (63304-131-01) | 2018-08-06 | 0000-00-00 | No | No | Current |
| 63304-131-10 | 63304013110 | 1000 TABLET, FILM COATED in 1 BOTTLE (63304-131-10) | 2018-08-06 | 0000-00-00 | No | No | Current |