Doxycycline Hyclate
- Product NDC
- 50268-278
- 11-digit product format
- 502680278
- Labeler code
- 50268
- Product ID
- 50268-278_461626eb-97e0-bb4c-e063-6394a90a10c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxycycline Hyclate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA062676
- Marketing category
- ANDA
- Marketing start
- 2014-06-04
- 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 | 1649405, 1649988, 1650143 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-278-11 | Doxycycline Hyclate | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 8 |
| 50268-278-15 | Doxycycline Hyclate | 50 in 1 BOX | CAPSULE | 50 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Doxycycline Hyclate | ACTIVE INGREDIENT | 19XTS3T51U | DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK] | 2 | |
| Doxycycline Anhydrous | ACTIVE MOIETY | 334895S862 | DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK] | 2 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK] | 2 | |
| carnauba wax | INACTIVE INGREDIENT | R12CBM0EIZ | DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK] | 2 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK] | 2 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK] | 2 | |
| D&C Red No. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK] | 2 | |
| D&C Yellow No. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK] | 2 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK] | 2 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK] | 2 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK] | 2 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK] | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK] | 2 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK] | 2 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK] | 2 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-278 | DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [AVPAK] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240110_53ff9f7e-0db0-c841-d334-4cf31f658828.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 |
|---|
| 50268-278-11 | 50268027811 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50268-278-15 | 50268027815 | 50 BLISTER PACK in 1 BOX (50268-278-15) / 1 CAPSULE in 1 BLISTER PACK (50268-278-11) | 50 blister pack | 2014-06-04 | 0000-00-00 | No | No | Current |