Carbamazepine
- Product NDC
- 70518-3176
- 11-digit product format
- 705183176
- Labeler code
- 70518
- Product ID
- 70518-3176_c833e685-b6f8-5cf3-e053-2a95a90a1788
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078986
- Marketing category
- ANDA
- Marketing start
- 2021-07-28
- Marketing end
- 0000-00-00
- Substance
- CARBAMAZEPINE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70518-3176 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 70518-3176 | 70518-3176-0 | D | Discontinued by firm | 2026-08-11 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-3176-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-3176-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-3176-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-3176-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-3176-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-3176-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-3176-0 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-3176-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-3176-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-3176-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-3176-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-3176-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078986-001 | CARBAMAZEPINE | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | |
| A078986-002 | CARBAMAZEPINE | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | |
| A078986-003 | CARBAMAZEPINE | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078986-001 | AB |
| A078986-002 | AB |
| A078986-003 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078986-001 | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078986-002 | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078986-003 | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078986-001 | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078986-002 | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078986-003 | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078986-001 | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078986-002 | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078986-003 | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078986-001 | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078986-002 | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078986-003 | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078986-001 | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078986-002 | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078986-003 | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078986-001 | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078986-002 | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078986-003 | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078986-001 | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078986-002 | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078986-003 | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078986-001 | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078986-002 | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078986-003 | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078986-001 | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078986-002 | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078986-003 | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078986-001 | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078986-002 | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078986-003 | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078986-001 | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078986-002 | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078986-003 | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078986-001 | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078986-002 | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078986-003 | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078986-001 | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078986-002 | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078986-003 | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078986-001 | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-11-25 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078986-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078986-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078986-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078986-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078986-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078986-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078986-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078986-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078986-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078986-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078986-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078986-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078986-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078986-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078986-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078986-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078986-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078986-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078986-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078986-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078986-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078986-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078986-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078986-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078986-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078986-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078986-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078986-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078986-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078986-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078986-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078986-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078986-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078986-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078986-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078986-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078986-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078986-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078986-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078986-001 | AB | 1 | 8072bd15b7f6… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70518-3176-0 | 2023-03-20 | C162847 | 48780-1 | f386c64a-14b3-0266-e053-dadaa90a7c1a | Carbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg Rx only |
| 70518-3176-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-14b3-0266-e053-dadaa90a7c1a | Carbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg Rx only |
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 |
|---|---|---|---|---|---|---|
| Carbamazepine | CARBAMAZEPINE | Major Pharmaceuticals | 2676f950-48b4-4bef-a792-ea4570de9aa6 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 078986 ANDA078986 |
| Carbamazepine | CARBAMAZEPINE | Bryant Ranch Prepack | 47d0ea82-9974-4d41-9ae1-5f1b11419a33 | 2026-02-12 | Boxed warning, Warnings, Adverse reactions | 078986 ANDA078986 |
| Carbamazepine | CARBAMAZEPINE | AvPAK | ceb84aa4-2041-6e6e-e053-2995a90a0f24 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 078986 ANDA078986 |
| Carbamazepine | CARBAMAZEPINE | Bryant Ranch Prepack | d684dfd8-1e0d-47a1-bf37-ada6413815f2 | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | 078986 ANDA078986 |
| Carbamazepine | CARBAMAZEPINE | Bryant Ranch Prepack | 0ccee1ed-3d7c-452b-9519-c1ddb92893df | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | 078986 ANDA078986 |
| Carbamazepine | CARBAMAZEPINE | Bryant Ranch Prepack | 1a8c4f15-9e75-4919-ac67-06102b82dd92 | 2025-10-30 | Boxed warning, Warnings, Adverse reactions | 078986 ANDA078986 |
| Carbamazepine | CARBAMAZEPINE | REMEDYREPACK INC. | e9d282f0-8bb7-4280-b83d-b70d83a04b93 | 2025-10-06 | Boxed warning, Warnings, Adverse reactions | 078986 ANDA078986 |
| Carbamazepine | CARBAMAZEPINE | Apotex Corp. | e91f9de3-3fdd-0a6b-71ce-53a2cc142816 | 2025-09-17 | Boxed warning, Warnings, Adverse reactions | 078986 ANDA078986 |
| Carbamazepine | CARBAMAZEPINE | Bryant Ranch Prepack | 46eef194-760d-43ea-86c5-341927277c91 | 2025-07-28 | Boxed warning, Warnings, Adverse reactions | 078986 ANDA078986 |
| Carbamazepine | CARBAMAZEPINE | Bryant Ranch Prepack | 4db57051-13bb-4038-ae58-e4d7f541450d | 2025-07-28 | Boxed warning, Warnings, Adverse reactions | 078986 ANDA078986 |
| Carbamazepine | CARBAMAZEPINE | Bryant Ranch Prepack | 34f75728-b9e8-48e7-e063-6394a90afc31 | 2025-05-12 | Boxed warning, Warnings, Adverse reactions | 078986 ANDA078986 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-3176-0 | 70518317600 | 30 POUCH in 1 BOX (70518-3176-0) > 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-3176-1) | 30 pouch | 2021-07-28 | 0000-00-00 | No | No | Current |