Doxycycline
- Product NDC
- 53002-0673
- 11-digit product format
- 530020673
- Labeler code
- 53002
- Product ID
- 53002-0673_d937921d-11a0-4ba2-aa44-aef5dd995401
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxycycline
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA065053
- Marketing category
- ANDA
- Marketing start
- 2000-12-26
- Marketing end
- 0000-00-00
- Substance
- DOXYCYCLINE
- Active strength
- 100 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 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 |
|---|---|---|---|---|---|
| 53002-0673-0 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8e05-d83d-e063-dadaa90ab31f | Package/Label Display Panel |
| 53002-0673-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8e05-d83d-e063-dadaa90ab31f | Package/Label Display Panel |
| 53002-0673-2 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8e05-d83d-e063-dadaa90ab31f | Package/Label Display Panel |
| 53002-0673-3 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8e05-d83d-e063-dadaa90ab31f | Package/Label Display Panel |
| 53002-0673-4 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8e05-d83d-e063-dadaa90ab31f | Package/Label Display Panel |
| 53002-0673-5 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8e05-d83d-e063-dadaa90ab31f | Package/Label Display Panel |
| 53002-0673-6 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8e05-d83d-e063-dadaa90ab31f | Package/Label Display Panel |
| 53002-0673-7 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8e05-d83d-e063-dadaa90ab31f | Package/Label Display Panel |
| 53002-0673-9 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8e05-d83d-e063-dadaa90ab31f | Package/Label Display Panel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-0673-0 | Doxycycline | 100 in 1 BOTTLE | CAPSULE | 100 | 1 | |
| 53002-0673-1 | Doxycycline | 2 in 1 BOTTLE | CAPSULE | 2 | 1 | |
| 53002-0673-2 | Doxycycline | 10 in 1 BOTTLE | CAPSULE | 10 | 1 | |
| 53002-0673-3 | Doxycycline | 14 in 1 BOTTLE | CAPSULE | 14 | 1 | |
| 53002-0673-4 | Doxycycline | 20 in 1 BOTTLE | CAPSULE | 20 | 1 | |
| 53002-0673-5 | Doxycycline | 28 in 1 BOTTLE | CAPSULE | 28 | 1 | |
| 53002-0673-6 | Doxycycline | 30 in 1 BOTTLE | CAPSULE | 30 | 1 | |
| 53002-0673-7 | Doxycycline | 40 in 1 BOTTLE | CAPSULE | 40 | 1 | |
| 53002-0673-9 | Doxycycline | 60 in 1 BOTTLE | CAPSULE | 60 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-0673 | DOXYCYCLINE CAPSULE [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 9 package rows | 20220331_e7a69d4c-8a7f-4641-821d-acf5d7be3d52.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1649990 | doxycycline monohydrate 100 MG Oral Capsule | PSN | e7a69d4c-8a7f-4641-821d-acf5d7be3d52 | 1 |
| 1649990 | doxycycline monohydrate 100 MG Oral Capsule | SCD | e7a69d4c-8a7f-4641-821d-acf5d7be3d52 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-0673-0 | 53002067300 | 100 CAPSULE in 1 BOTTLE (53002-0673-0) | 100 capsule | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-0673-1 | 53002067301 | 2 CAPSULE in 1 BOTTLE (53002-0673-1) | 2 capsule | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-0673-2 | 53002067302 | 10 CAPSULE in 1 BOTTLE (53002-0673-2) | 10 capsule | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-0673-3 | 53002067303 | 14 CAPSULE in 1 BOTTLE (53002-0673-3) | 14 capsule | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-0673-4 | 53002067304 | 20 CAPSULE in 1 BOTTLE (53002-0673-4) | 20 capsule | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-0673-5 | 53002067305 | 28 CAPSULE in 1 BOTTLE (53002-0673-5) | 28 capsule | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-0673-6 | 53002067306 | 30 CAPSULE in 1 BOTTLE (53002-0673-6) | 30 capsule | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-0673-7 | 53002067307 | 40 CAPSULE in 1 BOTTLE (53002-0673-7) | 40 capsule | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-0673-9 | 53002067309 | 60 CAPSULE in 1 BOTTLE (53002-0673-9) | 60 capsule | 2021-01-01 | 0000-00-00 | No | No | Current |