Tramadol Hydrochloride
- Product NDC
- 68387-900
- 11-digit product format
- 683870900
- Labeler code
- 68387
- Product ID
- 68387-900_d24bc5c8-18dc-40a6-b54f-7d4e20175950
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Keltman Pharmaceuticals Inc.
- Application
- ANDA076003
- Marketing category
- ANDA
- Marketing start
- 2009-06-30
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- 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 |
|---|---|---|---|
| 43d017e1-6ae6-7555-71d1-c249236d6f26 | Product name | 4 | 20251117 |
| bff1fbab-f4cc-4993-b7de-2b555ee5eb73 | Product name | 1 | 20220509 |
| c563c906-2606-457c-bb1b-5a623daed55b | Product name | 1 | 20210511 |
| 43a9f8f9-34aa-8ae8-719e-5489454f7720 | Product name | 5 | 20200123 |
| abd2f6f2-3fa7-4571-af8a-d67f89bdcb75 | Product name | 1 | 20190927 |
| 377068df-225f-7318-a910-a1987cdfa361 | Product name | 3 | 20170608 |
| 9457302e-0ca3-d9ff-0863-1b24b6107218 | Product name | 1 | 20140508 |
| d5c49867-1fe9-7a44-3319-814417011d51 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68387-900-12 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c420-621f-e053-dbdaa90a74ad | Tramadol Hydrochloride Tablets |
| 68387-900-15 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c420-621f-e053-dbdaa90a74ad | Tramadol Hydrochloride Tablets |
| 68387-900-20 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c420-621f-e053-dbdaa90a74ad | Tramadol Hydrochloride Tablets |
| 68387-900-24 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c420-621f-e053-dbdaa90a74ad | Tramadol Hydrochloride Tablets |
| 68387-900-30 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c420-621f-e053-dbdaa90a74ad | Tramadol Hydrochloride Tablets |
| 68387-900-40 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c420-621f-e053-dbdaa90a74ad | Tramadol Hydrochloride Tablets |
| 68387-900-50 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c420-621f-e053-dbdaa90a74ad | Tramadol Hydrochloride Tablets |
| 68387-900-60 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c420-621f-e053-dbdaa90a74ad | Tramadol Hydrochloride Tablets |
| 68387-900-90 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c420-621f-e053-dbdaa90a74ad | Tramadol Hydrochloride Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68387-900-12 | Tramadol Hydrochloride | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | 1 | |
| 68387-900-15 | Tramadol Hydrochloride | 15 in 1 BOTTLE, PLASTIC | TABLET | 15 | 1 | |
| 68387-900-20 | Tramadol Hydrochloride | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | 1 | |
| 68387-900-24 | Tramadol Hydrochloride | 240 in 1 BOTTLE, PLASTIC | TABLET | 240 | 1 | |
| 68387-900-30 | Tramadol Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 1 | |
| 68387-900-40 | Tramadol Hydrochloride | 40 in 1 BOTTLE, PLASTIC | TABLET | 40 | 1 | |
| 68387-900-50 | Tramadol Hydrochloride | 50 in 1 BOTTLE, PLASTIC | TABLET | 50 | 1 | |
| 68387-900-60 | Tramadol Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | 1 | |
| 68387-900-90 | Tramadol Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68387-900-12 | EA - Each | 68387-900 | 101e6667-74d7-4af1-a524-b88f7b963d35 | 1 | 2012-07-24 |
| 68387-900-15 | EA - Each | 68387-900 | d6de4314-6d80-4421-b204-5875676bddc7 | 1 | 2012-07-24 |
| 68387-900-20 | EA - Each | 68387-900 | 9a6f58d6-642f-4f09-85be-0a02240abfdc | 1 | 2012-07-24 |
| 68387-900-24 | EA - Each | 68387-900 | 452bbe32-637e-4561-9f10-7b47bfafbe9d | 1 | 2012-07-24 |
| 68387-900-30 | EA - Each | 68387-900 | 721c1fea-d2e3-4417-9dfe-663cbbb3dec9 | 1 | 2012-07-24 |
| 68387-900-40 | EA - Each | 68387-900 | a492b345-0b45-4a89-a3ed-bd2aae5ba363 | 1 | 2012-07-24 |
| 68387-900-50 | EA - Each | 68387-900 | 7ee4ba19-d22a-4b17-be77-182c5bdea104 | 1 | 2012-07-24 |
| 68387-900-60 | EA - Each | 68387-900 | ad2e0cc7-4973-4b70-ad9c-98fdd3bf538a | 1 | 2012-07-24 |
| 68387-900-90 | EA - Each | 68387-900 | c0bcad67-a87d-46f4-88c2-bd777160152c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE | ACTIVE INGREDIENT | 9N7R477WCK | TRAMADOL HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| TRAMADOL | ACTIVE MOIETY | 39J1LGJ30J | TRAMADOL HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 835603 | traMADol HCl 50 MG Oral Tablet | PSN | 340a7760-50b1-4825-9766-eaaad0dd7712 | 1 |
| 835603 | tramadol hydrochloride 50 MG Oral Tablet | SCD | 340a7760-50b1-4825-9766-eaaad0dd7712 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68387-900-12 | 68387090012 | 120 in 1 BOTTLE, PLASTIC | Historical |
| 68387-900-15 | 68387090015 | 15 in 1 BOTTLE, PLASTIC | Historical |
| 68387-900-20 | 68387090020 | 20 in 1 BOTTLE, PLASTIC | Historical |
| 68387-900-24 | 68387090024 | 240 in 1 BOTTLE, PLASTIC | Historical |
| 68387-900-30 | 68387090030 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 68387-900-40 | 68387090040 | 40 in 1 BOTTLE, PLASTIC | Historical |
| 68387-900-50 | 68387090050 | 50 in 1 BOTTLE, PLASTIC | Historical |
| 68387-900-60 | 68387090060 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 68387-900-90 | 68387090090 | 90 in 1 BOTTLE, PLASTIC | Historical |