phendimetrazine tartrate
- Product NDC
- 12634-028
- 11-digit product format
- 126340028
- Labeler code
- 12634
- Product ID
- 12634-028_375fdeb5-e1ca-1a8e-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- phendimetrazine tartrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotheca Inc.
- Application
- ANDA089452
- Marketing category
- ANDA
- Marketing start
- 2000-06-27
- Marketing end
- 0000-00-00
- Substance
- PHENDIMETRAZINE TARTRATE
- Active strength
- 35 mg/1
- Pharmacologic classes
- Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 12634-028 | I | Inactivated by FDA | 2026-07-31 | ||
| excluded package | package | 12634-028 | 12634-028-00 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-01 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-09 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-40 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-42 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-45 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-50 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-52 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-54 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-57 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-58 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-59 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-60 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-61 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-63 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-66 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-67 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-69 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-71 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-74 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-78 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-79 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-80 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-81 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-82 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-84 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-85 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-90 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-91 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-92 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-93 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-94 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-95 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-96 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-97 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-98 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 12634-028 | 12634-028-99 | I | Inactivated by FDA | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A089452-001 | PHENDIMETRAZINE TARTRATE | PHENDIMETRAZINE TARTRATE | 35MG | TABLET / ORAL | AA | 1991-10-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A089452-001 | AA |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 71525015-bcb9-5864-7749-4b5f528a6b6a | Product name | 2 | 20180419 |
| 977c925f-5460-67b1-e843-25a0ba370df1 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 12634-028-00 | phendimetrazine tartrate | 10 in 1 BOTTLE | TABLET | 10 | 4 | |
| 12634-028-01 | phendimetrazine tartrate | 100 in 1 BOTTLE | TABLET | 100 | 4 | |
| 12634-028-09 | phendimetrazine tartrate | 35 in 1 BOTTLE | TABLET | 35 | 4 | |
| 12634-028-40 | phendimetrazine tartrate | 40 in 1 BOTTLE | TABLET | 40 | 4 | |
| 12634-028-42 | phendimetrazine tartrate | 42 in 1 BOTTLE | TABLET | 42 | 4 | |
| 12634-028-45 | phendimetrazine tartrate | 45 in 1 BOTTLE | TABLET | 45 | 4 | |
| 12634-028-50 | phendimetrazine tartrate | 50 in 1 BOTTLE | TABLET | 50 | 4 | |
| 12634-028-52 | phendimetrazine tartrate | 12 in 1 BLISTER PACK | TABLET | 12 | 4 | |
| 12634-028-54 | phendimetrazine tartrate | 14 in 1 BLISTER PACK | TABLET | 14 | 4 | |
| 12634-028-57 | phendimetrazine tartrate | 20 in 1 BLISTER PACK | TABLET | 20 | 4 | |
| 12634-028-58 | phendimetrazine tartrate | 28 in 1 BLISTER PACK | TABLET | 28 | 4 | |
| 12634-028-59 | phendimetrazine tartrate | 30 in 1 BLISTER PACK | TABLET | 30 | 4 | |
| 12634-028-60 | phendimetrazine tartrate | 60 in 1 BOTTLE | TABLET | 60 | 4 | |
| 12634-028-61 | phendimetrazine tartrate | 10 in 1 BLISTER PACK | TABLET | 10 | 4 | |
| 12634-028-63 | phendimetrazine tartrate | 3 in 1 BLISTER PACK | TABLET | 3 | 4 | |
| 12634-028-66 | phendimetrazine tartrate | 6 in 1 BLISTER PACK | TABLET | 6 | 4 | |
| 12634-028-67 | phendimetrazine tartrate | 7 in 1 BLISTER PACK | TABLET | 7 | 4 | |
| 12634-028-69 | phendimetrazine tartrate | 9 in 1 BLISTER PACK | TABLET | 9 | 4 | |
| 12634-028-71 | phendimetrazine tartrate | 30 in 1 BOTTLE | TABLET | 30 | 4 | |
| 12634-028-74 | phendimetrazine tartrate | 24 in 1 BOTTLE | TABLET | 24 | 4 | |
| 12634-028-78 | phendimetrazine tartrate | 28 in 1 BOTTLE | TABLET | 28 | 4 | |
| 12634-028-79 | phendimetrazine tartrate | 25 in 1 BOTTLE | TABLET | 25 | 4 | |
| 12634-028-80 | phendimetrazine tartrate | 20 in 1 BOTTLE | TABLET | 20 | 4 | |
| 12634-028-81 | phendimetrazine tartrate | 21 in 1 BOTTLE | TABLET | 21 | 4 | |
| 12634-028-82 | phendimetrazine tartrate | 12 in 1 BOTTLE | TABLET | 12 | 4 | |
| 12634-028-84 | phendimetrazine tartrate | 14 in 1 BOTTLE | TABLET | 14 | 4 | |
| 12634-028-85 | phendimetrazine tartrate | 15 in 1 BOTTLE | TABLET | 15 | 4 | |
| 12634-028-90 | phendimetrazine tartrate | 90 in 1 BOTTLE | TABLET | 90 | 4 | |
| 12634-028-91 | phendimetrazine tartrate | 1 in 1 BLISTER PACK | TABLET | 1 | 4 | |
| 12634-028-92 | phendimetrazine tartrate | 2 in 1 BOTTLE | TABLET | 2 | 4 | |
| 12634-028-93 | phendimetrazine tartrate | 3 in 1 BOTTLE | TABLET | 3 | 4 | |
| 12634-028-94 | phendimetrazine tartrate | 4 in 1 BOTTLE | TABLET | 4 | 4 | |
| 12634-028-95 | phendimetrazine tartrate | 5 in 1 BOTTLE | TABLET | 5 | 4 | |
| 12634-028-96 | phendimetrazine tartrate | 6 in 1 BOTTLE | TABLET | 6 | 4 | |
| 12634-028-97 | phendimetrazine tartrate | 7 in 1 BOTTLE | TABLET | 7 | 4 | |
| 12634-028-98 | phendimetrazine tartrate | 8 in 1 BOTTLE | TABLET | 8 | 4 | |
| 12634-028-99 | phendimetrazine tartrate | 9 in 1 BOTTLE | TABLET | 9 | 4 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PHENDIMETRAZINE TARTRATE | ACTIVE INGREDIENT | 6985IP0T80 | PHENDIMETRAZINE TARTRATE TABLET [APOTHECA, INC.] | 2 | |
| PHENDIMETRAZINE | ACTIVE MOIETY | AB2794W8KV | PHENDIMETRAZINE TARTRATE TABLET [APOTHECA, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PHENDIMETRAZINE TARTRATE TABLET [APOTHECA, INC.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | PHENDIMETRAZINE TARTRATE TABLET [APOTHECA, INC.] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | PHENDIMETRAZINE TARTRATE TABLET [APOTHECA, INC.] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | PHENDIMETRAZINE TARTRATE TABLET [APOTHECA, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PHENDIMETRAZINE TARTRATE TABLET [APOTHECA, INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PHENDIMETRAZINE TARTRATE TABLET [APOTHECA, INC.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 979549 | phendimetrazine tartrate 35 MG Oral Tablet | PSN | b045cbd6-68ca-4a9b-a6e6-625d736a079b | 4 |
| 979549 | phendimetrazine tartrate 35 MG Oral Tablet | SCD | b045cbd6-68ca-4a9b-a6e6-625d736a079b | 4 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 12634-028-00 | 12634002800 | 10 in 1 BOTTLE | Historical |
| 12634-028-01 | 12634002801 | 100 in 1 BOTTLE | Historical |
| 12634-028-09 | 12634002809 | 35 in 1 BOTTLE | Historical |
| 12634-028-40 | 12634002840 | 40 in 1 BOTTLE | Historical |
| 12634-028-42 | 12634002842 | 42 in 1 BOTTLE | Historical |
| 12634-028-45 | 12634002845 | 45 in 1 BOTTLE | Historical |
| 12634-028-50 | 12634002850 | 50 in 1 BOTTLE | Historical |
| 12634-028-52 | 12634002852 | 12 in 1 BLISTER PACK | Historical |
| 12634-028-54 | 12634002854 | 14 in 1 BLISTER PACK | Historical |
| 12634-028-57 | 12634002857 | 20 in 1 BLISTER PACK | Historical |
| 12634-028-58 | 12634002858 | 28 in 1 BLISTER PACK | Historical |
| 12634-028-59 | 12634002859 | 30 in 1 BLISTER PACK | Historical |
| 12634-028-60 | 12634002860 | 60 in 1 BOTTLE | Historical |
| 12634-028-61 | 12634002861 | 10 in 1 BLISTER PACK | Historical |
| 12634-028-63 | 12634002863 | 3 in 1 BLISTER PACK | Historical |
| 12634-028-66 | 12634002866 | 6 in 1 BLISTER PACK | Historical |
| 12634-028-67 | 12634002867 | 7 in 1 BLISTER PACK | Historical |
| 12634-028-69 | 12634002869 | 9 in 1 BLISTER PACK | Historical |
| 12634-028-71 | 12634002871 | 30 in 1 BOTTLE | Historical |
| 12634-028-74 | 12634002874 | 24 in 1 BOTTLE | Historical |
| 12634-028-78 | 12634002878 | 28 in 1 BOTTLE | Historical |
| 12634-028-79 | 12634002879 | 25 in 1 BOTTLE | Historical |
| 12634-028-80 | 12634002880 | 20 in 1 BOTTLE | Historical |
| 12634-028-81 | 12634002881 | 21 in 1 BOTTLE | Historical |
| 12634-028-82 | 12634002882 | 12 in 1 BOTTLE | Historical |
| 12634-028-84 | 12634002884 | 14 in 1 BOTTLE | Historical |
| 12634-028-85 | 12634002885 | 15 in 1 BOTTLE | Historical |
| 12634-028-90 | 12634002890 | 90 in 1 BOTTLE | Historical |
| 12634-028-91 | 12634002891 | 1 in 1 BLISTER PACK | Historical |
| 12634-028-92 | 12634002892 | 2 in 1 BOTTLE | Historical |
| 12634-028-93 | 12634002893 | 3 in 1 BOTTLE | Historical |
| 12634-028-94 | 12634002894 | 4 in 1 BOTTLE | Historical |
| 12634-028-95 | 12634002895 | 5 in 1 BOTTLE | Historical |
| 12634-028-96 | 12634002896 | 6 in 1 BOTTLE | Historical |
| 12634-028-97 | 12634002897 | 7 in 1 BOTTLE | Historical |
| 12634-028-98 | 12634002898 | 8 in 1 BOTTLE | Historical |
| 12634-028-99 | 12634002899 | 9 in 1 BOTTLE | Historical |