Doxycycline Hyclate
- Product NDC
- 53489-647
- 11-digit product format
- 534890647
- Labeler code
- 53489
- Product ID
- 53489-647_31dd6775-5a9a-9e21-e063-6294a90aa546
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxycycline Hyclate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA065134
- Marketing category
- ANDA
- Marketing start
- 2005-05-13
- 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 |
|---|
| 53489-647-01 | Doxycycline Hyclate | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 8 |
| 53489-647-03 | Doxycycline Hyclate | 250 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 250 | | 8 |
| 53489-647-05 | Doxycycline Hyclate | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 8 |
| 53489-647-06 | Doxycycline Hyclate | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 8 |
| 53489-647-07 | Doxycycline Hyclate | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 8 |
| 53489-647-10 | Doxycycline Hyclate | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 8 |
| 53489-647-90 | Doxycycline Hyclate | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 8 |
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 [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| Doxycycline Hyclate | ACTIVE INGREDIENT | 19XTS3T51U | DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 3 | |
| Doxycycline Anhydrous | ACTIVE MOIETY | 334895S862 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| Doxycycline Anhydrous | ACTIVE MOIETY | 334895S862 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 3 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 3 | |
| carnauba wax | INACTIVE INGREDIENT | R12CBM0EIZ | DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| carnauba wax | INACTIVE INGREDIENT | R12CBM0EIZ | DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 3 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 3 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 3 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 3 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 3 | |
| polydextrose | INACTIVE INGREDIENT | VH2XOU12IE | DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 3 | |
| polydextrose | INACTIVE INGREDIENT | VH2XOU12IE | DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 3 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 3 | |
| triacetin | INACTIVE INGREDIENT | XHX3C3X673 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 3 | |
| triacetin | INACTIVE INGREDIENT | XHX3C3X673 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53489-647 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 8 | Current NDC, Legacy NDC, 7 package rows | 20250406_bff3f426-44fc-4dbf-96df-df44011103e8.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 |
|---|
| 53489-647-01 | 53489064701 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-01) | 2005-05-13 | 0000-00-00 | No | No | Current |
| 53489-647-03 | 53489064703 | 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-03) | 2005-05-13 | 0000-00-00 | No | No | Current |
| 53489-647-05 | 53489064705 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-05) | 2005-05-13 | 0000-00-00 | No | No | Current |
| 53489-647-06 | 53489064706 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-06) | 2005-05-13 | 0000-00-00 | No | No | Current |
| 53489-647-07 | 53489064707 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-07) | 2005-05-13 | 0000-00-00 | No | No | Current |
| 53489-647-10 | 53489064710 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-10) | 2005-05-13 | 0000-00-00 | No | No | Current |
| 53489-647-90 | 53489064790 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-90) | 2005-05-13 | 0000-00-00 | No | No | Current |