Doxycycline Hyclate
- Product NDC
- 68047-714
- 11-digit product format
- 680470714
- Labeler code
- 68047
- Product ID
- 68047-714_3b3e9b64-b623-f126-e063-6394a90a90c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxycycline Hyclate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Larken Laboratories, Inc.
- Application
- ANDA065287
- Marketing category
- ANDA
- Marketing start
- 2010-11-15
- Substance
- DOXYCYCLINE HYCLATE
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19XTS3T51U |
| Rxcui | 283535 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68047-714-01 | Doxycycline Hyclate | 100 in 1 BOTTLE | TABLET | 100 | | 14 |
| 68047-714-60 | Doxycycline Hyclate | 60 in 1 BOTTLE | TABLET | 60 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DOXYCYCLINE HYCLATE | ACTIVE INGREDIENT | 19XTS3T51U | DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] | 1 | |
| DOXYCYCLINE | ACTIVE MOIETY | N12000U13O | DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] | 1 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68047-714 | DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20241012_49f82130-6f8a-412c-b625-e75906e74675.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 |
|---|
| 68047-714-01 | 68047071401 | 100 TABLET in 1 BOTTLE (68047-714-01) | 100 tablet | 2010-11-15 | 0000-00-00 | No | No | Current |
| 68047-714-60 | 68047071460 | 60 TABLET in 1 BOTTLE (68047-714-60) | 60 tablet | 2010-11-15 | 0000-00-00 | No | No | Current |