Doxycycline Hyclate
- Product NDC
- 68308-716
- 11-digit product format
- 683080716
- Labeler code
- 68308
- Product ID
- 68308-716_fe12dd75-ce55-4035-9193-0182bc4f5ba6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxycycline Hyclate
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Mayne Pharma Commercial LLC
- Application
- NDA050795
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2016-02-01
- Substance
- DOXYCYCLINE HYCLATE
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19XTS3T51U |
| Rxcui | 406524, 434018, 799048, 1423080 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68308-716-30 | Doxycycline Hyclate | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 15 |
| 68308-716-60 | Doxycycline Hyclate | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Doxycycline Hyclate | ACTIVE INGREDIENT | 19XTS3T51U | DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES] | 3 | |
| Doxycycline Anhydrous | ACTIVE MOIETY | 334895S862 | DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES] | 3 | |
| Anhydrous Lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES] | 3 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES] | 3 | |
| Crospovidone | INACTIVE INGREDIENT | 68401960MK | DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES] | 3 | |
| Lactose Monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES] | 3 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES] | 3 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES] | 3 | |
| Sodium Lauryl Sulfate | INACTIVE INGREDIENT | 368GB5141J | DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES] | 3 | |
| Starch, Corn | INACTIVE INGREDIENT | O8232NY3SJ | DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES] | 3 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68308-716 | DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MAYNE PHARMA COMMERCIAL LLC] | 15 | Current NDC, Legacy NDC, 2 package rows | 20250417_cd2ab9b8-9619-4199-8a5d-83377b3274d1.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 |
|---|
| 68308-716-30 | 68308071630 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68308-716-30) | 2017-12-18 | 0000-00-00 | No | No | Current |
| 68308-716-60 | 68308071660 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68308-716-60) | 2016-02-01 | 0000-00-00 | No | No | Current |