Carbamazepine
- Product NDC
- 60505-2805
- 11-digit product format
- 605052805
- Labeler code
- 60505
- Product ID
- 60505-2805_697610a8-e6e7-b0d0-ef1b-2507d5b73c53
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA078986
- Marketing category
- ANDA
- Marketing start
- 2012-03-23
- Substance
- CARBAMAZEPINE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 package | package | 60505-2805 | 60505-2805-3 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 60505-2805 | 60505-2805-8 | 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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 60505-2805-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 60505-2805-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 60505-2805-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 60505-2805-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 60505-2805-8 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 60505-2805-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 60505-2805-8 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 60505-2805-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 60505-2805-8 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 60505-2805-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 60505-2805-8 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 60505-2805-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 60505-2805-8 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 60505-2805-3 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 60505-2805-8 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 60505-2805-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 60505-2805-8 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 60505-2805-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 60505-2805-8 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 60505-2805-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 60505-2805-8 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 60505-2805-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 60505-2805-8 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 60505-2805-3 | 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… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Carbamazepine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CARBAMAZEPINE | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 33CM23913M | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e91f9de3-3fdd-0a6b-71ce-53a2cc142816 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 26452c40-1589-928d-2fae-b84a1d1cf183 | Product name | 9 | 20251105 |
| 2275add5-bc9e-431c-8e27-74c11f3127d5 | Product name | 1 | 20200728 |
| 7c710123-0208-426b-be07-b37720f2767d | Product name | 1 | 20161206 |
| 8448f819-8511-2a70-1d0e-32e16eac918d | Product name | 1 | 20140508 |
| fee3eefd-cade-4e53-89b7-9d28964e1bc7 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60505-2805-3 | Carbamazepine | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | 15 | |
| 60505-2805-7 | Carbamazepine | 120 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 120 | 15 | |
| 60505-2805-8 | Carbamazepine | 1000 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 1000 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-2805-7 | EA - Each | 60505-2805 | a240e407-2f26-47eb-a74b-56925f8122d5 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CARBAMAZEPINE | ACTIVE INGREDIENT | 33CM23913M | CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| CARBAMAZEPINE | ACTIVE MOIETY | 33CM23913M | CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| ETHYLCELLULOSE (7 MPA.S) | INACTIVE INGREDIENT | H3UP11403C | CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60505-2805 | CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 14 | Current NDC, Legacy NDC, 3 package rows | 20240922_e91f9de3-3fdd-0a6b-71ce-53a2cc142816.zip |
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 60505-2805 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 388311 | carBAMazepine 100 MG 12HR Extended Release Oral Capsule | PSN | 1a8c4f15-9e75-4919-ac67-06102b82dd92 | 100 |
| 388311 | 12 HR carbamazepine 100 MG Extended Release Oral Capsule | SCD | 1a8c4f15-9e75-4919-ac67-06102b82dd92 | 100 |
| 388311 | carbamazepine 100 MG 12 HR Extended Release Oral Capsule | SY | 1a8c4f15-9e75-4919-ac67-06102b82dd92 | 100 |
| 388311 | carBAMazepine 100 MG 12HR Extended Release Oral Capsule | PSN | e91f9de3-3fdd-0a6b-71ce-53a2cc142816 | 15 |
| 200133 | carBAMazepine 200 MG 12HR Extended Release Oral Capsule | PSN | e91f9de3-3fdd-0a6b-71ce-53a2cc142816 | 15 |
| 200131 | carBAMazepine 300 MG 12HR Extended Release Oral Capsule | PSN | e91f9de3-3fdd-0a6b-71ce-53a2cc142816 | 15 |
| 388311 | 12 HR carbamazepine 100 MG Extended Release Oral Capsule | SCD | e91f9de3-3fdd-0a6b-71ce-53a2cc142816 | 15 |
| 200133 | 12 HR carbamazepine 200 MG Extended Release Oral Capsule | SCD | e91f9de3-3fdd-0a6b-71ce-53a2cc142816 | 15 |
| 200131 | 12 HR carbamazepine 300 MG Extended Release Oral Capsule | SCD | e91f9de3-3fdd-0a6b-71ce-53a2cc142816 | 15 |
| 388311 | carbamazepine 100 MG 12 HR Extended Release Oral Capsule | SY | e91f9de3-3fdd-0a6b-71ce-53a2cc142816 | 15 |
| 200133 | carbamazepine 200 MG 12 HR Extended Release Oral Capsule | SY | e91f9de3-3fdd-0a6b-71ce-53a2cc142816 | 15 |
| 200131 | carbamazepine 300 MG 12 HR Extended Release Oral Capsule | SY | e91f9de3-3fdd-0a6b-71ce-53a2cc142816 | 15 |
| 388311 | carBAMazepine 100 MG 12HR Extended Release Oral Capsule | PSN | ceb84aa4-2041-6e6e-e053-2995a90a0f24 | 4 |
| 200133 | carBAMazepine 200 MG 12HR Extended Release Oral Capsule | PSN | ceb84aa4-2041-6e6e-e053-2995a90a0f24 | 4 |
| 200131 | carBAMazepine 300 MG 12HR Extended Release Oral Capsule | PSN | ceb84aa4-2041-6e6e-e053-2995a90a0f24 | 4 |
| 388311 | 12 HR carbamazepine 100 MG Extended Release Oral Capsule | SCD | ceb84aa4-2041-6e6e-e053-2995a90a0f24 | 4 |
| 200133 | 12 HR carbamazepine 200 MG Extended Release Oral Capsule | SCD | ceb84aa4-2041-6e6e-e053-2995a90a0f24 | 4 |
| 200131 | 12 HR carbamazepine 300 MG Extended Release Oral Capsule | SCD | ceb84aa4-2041-6e6e-e053-2995a90a0f24 | 4 |
| 388311 | carbamazepine 100 MG 12 HR Extended Release Oral Capsule | SY | ceb84aa4-2041-6e6e-e053-2995a90a0f24 | 4 |
| 200133 | carbamazepine 200 MG 12 HR Extended Release Oral Capsule | SY | ceb84aa4-2041-6e6e-e053-2995a90a0f24 | 4 |
| 200131 | carbamazepine 300 MG 12 HR Extended Release Oral Capsule | SY | ceb84aa4-2041-6e6e-e053-2995a90a0f24 | 4 |
| 388311 | carBAMazepine 100 MG 12HR Extended Release Oral Capsule | PSN | 47d0ea82-9974-4d41-9ae1-5f1b11419a33 | 1 |
| 388311 | 12 HR carbamazepine 100 MG Extended Release Oral Capsule | SCD | 47d0ea82-9974-4d41-9ae1-5f1b11419a33 | 1 |
| 388311 | carbamazepine 100 MG 12 HR Extended Release Oral Capsule | SY | 47d0ea82-9974-4d41-9ae1-5f1b11419a33 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60505-2805-3 | 60505280503 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-2805-3) | 2012-03-23 | 2023-03-31 | No | No | Current |
| 60505-2805-7 | 60505280507 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-2805-7) | 2012-03-23 | 2023-03-31 | No | No | Current |
| 60505-2805-8 | 60505280508 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-2805-8) | 2012-03-23 | 2023-03-31 | No | No | Current |