Doxylamine Succinate and Pyridoxine Hydrochloride
- Product NDC
- 49884-186
- 11-digit product format
- 498840186
- Labeler code
- 49884
- Product ID
- 49884-186_19e74a3b-edba-41e5-afe6-fba1b9765ad1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Endo USA, Inc.
- Application
- ANDA208518
- Marketing category
- ANDA
- Marketing start
- 2019-12-19
- Substance
- DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
- Active strength
- 10; 10 mg/1; mg/1
- Pharmacologic classes
- Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Doxylamine Succinate and Pyridoxine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOXYLAMINE SUCCINATE | 10 mg/1 |
| PYRIDOXINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | V9BI9B5YI2, 68Y4CF58BV |
| Rxcui | 1375948 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49884-186-01 | Doxylamine Succinate and Pyridoxine Hydrochloride | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49884-186-01 | EA - Each | 49884-186 | 264410d8-549c-4e33-b633-a60ab238eaf3 | 1 | 2020-01-03 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49884-186 | DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DELAYED RELEASE TABLETS 10 MG/10 MG) TABLET, DELAYED RELEASE [ENDO USA, INC.] | 13 | Current NDC, Legacy NDC, 1 package rows | 20241212_de265fd1-bc22-4da1-aab5-b5fedd649c8b.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1375948 | doxylamine succinate 10 MG / pyridoxine HCl 10 MG Delayed Release Oral Tablet | PSN | c283720d-f9a5-471f-9616-853a70f2b31d | 102 |
| 1375948 | doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral Tablet | SCD | c283720d-f9a5-471f-9616-853a70f2b31d | 102 |
| 1375948 | doxylamine succinate 10 MG / vit-B6 Hydrochloride 10 MG Delayed Release Oral Tablet | SY | c283720d-f9a5-471f-9616-853a70f2b31d | 102 |
| 1375948 | doxylamine succinate 10 MG / vitamin B6 Hydrochloride 10 MG Delayed Release Oral Tablet | SY | c283720d-f9a5-471f-9616-853a70f2b31d | 102 |
| 1375948 | doxylamine succinate 10 MG / pyridoxine HCl 10 MG Delayed Release Oral Tablet | PSN | 172f1b4f-4b9f-4ba4-97f6-769cfec6e0d7 | 100 |
| 1375948 | doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral Tablet | SCD | 172f1b4f-4b9f-4ba4-97f6-769cfec6e0d7 | 100 |
| 1375948 | doxylamine succinate 10 MG / vit-B6 Hydrochloride 10 MG Delayed Release Oral Tablet | SY | 172f1b4f-4b9f-4ba4-97f6-769cfec6e0d7 | 100 |
| 1375948 | doxylamine succinate 10 MG / vitamin B6 Hydrochloride 10 MG Delayed Release Oral Tablet | SY | 172f1b4f-4b9f-4ba4-97f6-769cfec6e0d7 | 100 |
| 1375948 | doxylamine succinate 10 MG / pyridoxine HCl 10 MG Delayed Release Oral Tablet | PSN | de265fd1-bc22-4da1-aab5-b5fedd649c8b | 13 |
| 1375948 | doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral Tablet | SCD | de265fd1-bc22-4da1-aab5-b5fedd649c8b | 13 |
| 1375948 | doxylamine succinate 10 MG / vit-B6 Hydrochloride 10 MG Delayed Release Oral Tablet | SY | de265fd1-bc22-4da1-aab5-b5fedd649c8b | 13 |
| 1375948 | doxylamine succinate 10 MG / vitamin B6 Hydrochloride 10 MG Delayed Release Oral Tablet | SY | de265fd1-bc22-4da1-aab5-b5fedd649c8b | 13 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 49884-186-01 | 49884018601 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (49884-186-01) | 2019-12-19 | 0000-00-00 | No | No | Current |