Tramadol Hydrochloride
- Product NDC
- 82804-298
- Requested package NDC
- 82804-298-30
- 11-digit product format
- 828040298
- Labeler code
- 82804
- Product ID
- 82804-298_aefc85bc-0820-4aee-8d94-313c5f1658f5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA209404
- Marketing category
- ANDA
- Marketing start
- 2025-01-31
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209404-001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | |
| A209404-002 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | |
| A209404-003 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209404-001 | AB1 |
| A209404-002 | AB1 |
| A209404-003 | AB1 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A209404-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209404-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209404-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A209404-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209404-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209404-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209404-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209404-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209404-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209404-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209404-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209404-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209404-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209404-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209404-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209404-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209404-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209404-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209404-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209404-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209404-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | b8a1b40f171c… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209404-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209404-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209404-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A209404-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209404-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209404-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A209404-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209404-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209404-003 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A209404-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209404-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209404-003 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209404-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209404-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209404-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209404-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209404-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209404-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209404-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209404-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209404-003 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209404-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209404-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209404-003 | AB1 | 1 | b8a1b40f171c… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209404-001 | AB1 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209404-002 | AB1 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209404-003 | AB1 | 1 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tramadol Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TRAMADOL HYDROCHLORIDE | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9N7R477WCK | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 833709 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| aefc85bc-0820-4aee-8d94-313c5f1658f5 | Available on FDA.report |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | aefc85bc-0820-4aee-8d94-313c5f1658f5 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 209404 ANDA209404 82804-298-30 82804-298 82804029830 |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Macleods Pharmaceuticals Limited | a07ed444-54e4-4d45-b6a1-6ea2f6dedc61 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | 209404 ANDA209404 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 82804-298-30 | 82804029830 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-298-30) | 2025-01-31 | No | No | Current |