Doxycycline Hyclate
- Product NDC
- 53401-300
- 11-digit product format
- 534010300
- Labeler code
- 53401
- Product ID
- 53401-300_cc8b4662-82e8-41ef-a112-17c110da6b66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxycycline Hyclate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - New Jersey, LLC
- Application
- ANDA062677
- Marketing category
- ANDA
- Marketing start
- 1986-07-10
- Marketing end
- 0000-00-00
- Substance
- DOXYCYCLINE HYCLATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Tetracycline-class Drug [EPC],Tetracyclines [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 53401-300-20 | Doxycycline Hyclate | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 3 |
| 53401-300-99 | Doxycycline Hyclate | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Doxycycline Hyclate | ACTIVE INGREDIENT | 19XTS3T51U | DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 3 | |
| Doxycycline Anhydrous | ACTIVE MOIETY | 334895S862 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 3 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 3 | |
| carnauba wax | INACTIVE INGREDIENT | R12CBM0EIZ | DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 3 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 3 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 3 | |
| D&C Yellow No. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 3 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 3 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 3 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 3 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 3 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 3 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53401-300 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 3 | Legacy NDC, 2 package rows | 20140409_465c5c54-d9b2-4ad5-a3f3-dbee6acfb985.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53401-300-20 | 53401030020 | 20 in 1 BOTTLE, PLASTIC | Historical |
| 53401-300-99 | 53401030099 | 100 in 1 BOTTLE, PLASTIC | Historical |