Doxycycline Hyclate
- Product NDC
- 64725-5440
- 11-digit product format
- 647255440
- Labeler code
- 64725
- Product ID
- 64725-5440_bee80872-6005-48dd-b96e-de49ba1610a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxycycline Hyclate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- TYA Pharmaceuticals
- Application
- ANDA062031
- Marketing category
- ANDA
- Marketing start
- 1977-02-14
- 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b4321c75-2e87-4d90-9726-9a28fb2293a3 | Product name | 3 | 20260112 |
| 5e99724e-0654-4aec-b7a2-0b9b10e312ee | Product name | 3 | 20250227 |
| d2d36660-68ce-7e7d-0630-ec4b0d859fad | Product name | 6 | 20220921 |
| a239f4dd-cf93-4660-b190-f97d000f249f | Product name | 7 | 20210607 |
| a9d03566-caeb-4466-8021-74599b048880 | Product name | 3 | 20210604 |
| 12750814-20f7-4f35-b5fa-dbc8811ba858 | Product name | 9 | 20201007 |
| 00a5dbaa-1b7d-4e56-be0c-fedc7bbf5ade | Product name | 1 | 20200706 |
| 7b4b06ac-8c50-45f0-9556-293ea558a294 | Product name | 1 | 20180808 |
| 6a5b4392-5ab0-af0d-e0be-47b34e9dbb84 | Product name | 5 | 20171121 |
| 01a4aa74-7e05-63bd-bc10-1b5ceb111371 | Product name | 2 | 20171115 |
| 58b1278c-6dce-49b6-a05e-ea16f389acba | Product name | 1 | 20160620 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64725-5440-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-64fc-f424-e053-dadaa90a57ce | Doxycycline Hyclate |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64725-5440-1 | Doxycycline Hyclate | 50 in 1 BOTTLE | CAPSULE | 50 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | ACTIVE INGREDIENT | 19XTS3T51U | DOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS] | 2 | |
| DOXYCYCLINE ANHYDROUS | ACTIVE MOIETY | 334895S862 | DOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64725-5440 | DOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS] | 2 | Legacy NDC, 1 package rows | 20141027_1b0820a9-cded-4d1b-a56e-ed543d215635.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1649988 | doxycycline hyclate 100 MG Oral Capsule | PSN | 1b0820a9-cded-4d1b-a56e-ed543d215635 | 2 |
| 1649988 | doxycycline hyclate 100 MG Oral Capsule | SCD | 1b0820a9-cded-4d1b-a56e-ed543d215635 | 2 |
| 1649988 | doxycycline (as doxycycline hyclate) 100 MG Oral Capsule | SY | 1b0820a9-cded-4d1b-a56e-ed543d215635 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 64725-5440-1 | 64725544001 | 50 in 1 BOTTLE | Historical |