Doxycycline Hyclate
- Product NDC
- 55289-502
- 11-digit product format
- 552890502
- Labeler code
- 55289
- Product ID
- 55289-502_e6ecbd49-1d06-06a9-e053-2995a90a8eb9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxycycline Hyclate
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA062396
- Marketing category
- ANDA
- Marketing start
- 1984-11-07
- Marketing end
- 0000-00-00
- Substance
- DOXYCYCLINE HYCLATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Tetracycline-class Drug [EPC], Tetracyclines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DOXYCYCLINE HYCLATE | ACTIVE INGREDIENT | 19XTS3T51U | DOXYCYCLINE HYCLATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| DOXYCYCLINE ANHYDROUS | ACTIVE MOIETY | 334895S862 | DOXYCYCLINE HYCLATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DOXYCYCLINE HYCLATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DOXYCYCLINE HYCLATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DOXYCYCLINE HYCLATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DOXYCYCLINE HYCLATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DOXYCYCLINE HYCLATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DOXYCYCLINE HYCLATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DOXYCYCLINE HYCLATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 14 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-502 | DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.] | 34 | Legacy NDC | 20240314_fef7f0c9-48a1-46b4-a19c-c23d272a8ca2.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55289-502-16 | 55289050216 | 16 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (55289-502-16) | 2016-02-09 | 0000-00-00 | No | No | Current |
| 55289-502-30 | 55289050230 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (55289-502-30) | 2016-02-09 | 0000-00-00 | No | No | Current |
| 55289-502-60 | 55289050260 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (55289-502-60) | 2016-02-09 | 0000-00-00 | No | No | Current |