doxycycline hyclate
- Product NDC
- 68999-984
- 11-digit product format
- 689990984
- Labeler code
- 68999
- Product ID
- 68999-984_40076faf-09c3-f4ab-e063-6394a90ab3c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxycycline hyclate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Chartwell Governmental & Specialty RX, LLC
- Application
- ANDA062500
- Marketing category
- ANDA
- Marketing start
- 1984-09-11
- Substance
- DOXYCYCLINE HYCLATE
- Active strength
- 50 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 |
|---|---|
| DOXYCYCLINE HYCLATE | 50 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | N12000U13O, 19XTS3T51U |
| Rxcui | 1649405, 1649988, 1650030, 1650143, 1652674 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68999-984-50 | doxycycline hyclate | 50 in 1 BOTTLE | CAPSULE | 50 | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68999-984 | DOXYCYCLINE HYCLATE TABLET, FILM COATED DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE POWDER, FOR SUSPENSION [CHARTWELL GOVERNMENTAL & SPECIALTY RX, LLC] | 9 | Current NDC, Legacy NDC, 1 package rows | 20230719_b8486639-7eb9-4610-9cd4-0e922045d592.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1649988 | doxycycline hyclate 100 MG Oral Capsule | PSN | b8486639-7eb9-4610-9cd4-0e922045d592 | 10 |
| 1650143 | doxycycline hyclate 100 MG Oral Tablet | PSN | b8486639-7eb9-4610-9cd4-0e922045d592 | 10 |
| 1649405 | doxycycline hyclate 50 MG Oral Capsule | PSN | b8486639-7eb9-4610-9cd4-0e922045d592 | 10 |
| 1652674 | doxycycline hyclate 50 MG Oral Tablet | PSN | b8486639-7eb9-4610-9cd4-0e922045d592 | 10 |
| 1650030 | doxycycline monohydrate 25 MG in 5 mL Oral Suspension | PSN | b8486639-7eb9-4610-9cd4-0e922045d592 | 10 |
| 1649988 | doxycycline hyclate 100 MG Oral Capsule | SCD | b8486639-7eb9-4610-9cd4-0e922045d592 | 10 |
| 1650143 | doxycycline hyclate 100 MG Oral Tablet | SCD | b8486639-7eb9-4610-9cd4-0e922045d592 | 10 |
| 1649405 | doxycycline hyclate 50 MG Oral Capsule | SCD | b8486639-7eb9-4610-9cd4-0e922045d592 | 10 |
| 1652674 | doxycycline hyclate 50 MG Oral Tablet | SCD | b8486639-7eb9-4610-9cd4-0e922045d592 | 10 |
| 1650030 | doxycycline monohydrate 5 MG/ML Oral Suspension | SCD | b8486639-7eb9-4610-9cd4-0e922045d592 | 10 |
| 1649988 | doxycycline (as doxycycline hyclate) 100 MG Oral Capsule | SY | b8486639-7eb9-4610-9cd4-0e922045d592 | 10 |
| 1650030 | doxycycline monohydrate 25 MG per 5 ML Oral Suspension | SY | b8486639-7eb9-4610-9cd4-0e922045d592 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68999-984-50 | 68999098450 | 50 CAPSULE in 1 BOTTLE (68999-984-50) | 50 capsule | 2021-09-01 | 0000-00-00 | No | No | Current |