Demeclocycline Hydrochloride
- Product NDC
- 42806-144
- 11-digit product format
- 428060144
- Labeler code
- 42806
- Product ID
- 42806-144_b84008e7-52db-4b3e-a12e-cb939852ff0f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Demeclocycline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Epic Pharma, LLC
- Application
- ANDA065447
- Marketing category
- ANDA
- Marketing start
- 2015-02-02
- Substance
- DEMECLOCYCLINE HYDROCHLORIDE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Demeclocycline Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEMECLOCYCLINE HYDROCHLORIDE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 29O079NTYT |
| Rxcui | 905341, 905347 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42806-144-01 | Demeclocycline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
| 42806-144-30 | Demeclocycline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 42806-144-48 | Demeclocycline Hydrochloride | 48 in 1 BOTTLE | TABLET, FILM COATED | 48 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEMECLOCYCLINE HYDROCHLORIDE | ACTIVE INGREDIENT | 29O079NTYT | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| DEMECLOCYCLINE | ACTIVE MOIETY | 5R5W9ICI6O | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| HYDROXYPROPYL CELLULOSE (TYPE L) | INACTIVE INGREDIENT | UKE75GEA7F | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| HYPROMELLOSE 2910 (10000 MPA.S) | INACTIVE INGREDIENT | 0HO1H52958 | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-144 | DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 8 | Current NDC, Legacy NDC, 3 package rows | 20231221_645af8f4-0843-4afb-9ddc-f587f38adb68.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42806-144-01 | 42806014401 | 100 TABLET, FILM COATED in 1 BOTTLE (42806-144-01) | 2015-02-02 | 0000-00-00 | No | No | Current |
| 42806-144-30 | 42806014430 | 30 TABLET, FILM COATED in 1 BOTTLE (42806-144-30) | 2015-02-02 | 0000-00-00 | No | No | Current |
| 42806-144-48 | 42806014448 | 48 TABLET, FILM COATED in 1 BOTTLE (42806-144-48) | 2015-02-02 | 0000-00-00 | No | No | Current |