ORACEA
- Product NDC
- 0299-3822
- 11-digit product format
- 002993822
- Labeler code
- 0299
- Product ID
- 0299-3822_67eef1b6-593a-4277-abd3-f3e60e7557b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DOXYCYCLINE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Galderma Laboratories, L.P.
- Application
- NDA050805
- Marketing category
- NDA
- Marketing start
- 2010-05-14
- Substance
- DOXYCYCLINE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Tetracycline-class Drug [EPC], Tetracyclines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ORACEA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXYCYCLINE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N12000U13O |
| Rxcui | 901399, 901401 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DOXYCYCLINE | ACTIVE INGREDIENT | N12000U13O | ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] | 10 | |
| DOXYCYCLINE ANHYDROUS | ACTIVE MOIETY | 334895S862 | ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] | 10 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] | 10 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] | 10 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] | 10 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] | 10 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] | 10 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] | 10 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] | 10 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] | 10 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0299-3822 | ORACEA (DOXYCYCLINE) CAPSULE [GALDERMA LABORATORIES, L.P.] | 19 | Current NDC, Legacy NDC, 10 package rows | 20250417_aa15c93a-ff4c-447a-8a21-96da506d8997.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0299-3822-02 | 00299382202 | 12 TRAY in 1 BOX (0299-3822-02) > 8 CARTON in 1 TRAY > 1 BLISTER PACK in 1 CARTON > 2 CAPSULE in 1 BLISTER PACK | 12 tray | 2015-02-01 | 0000-00-00 | No | No | Current |
| 0299-3822-04 | 00299382204 | 4 CAPSULE in 1 BLISTER PACK (0299-3822-04) | 4 capsule | 2010-05-14 | 0000-00-00 | No | No | Current |
| 0299-3822-05 | 00299382205 | 8 BLISTER PACK in 1 PACKAGE (0299-3822-05) > 4 CAPSULE in 1 BLISTER PACK | 8 blister pack | 2010-05-14 | 0000-00-00 | No | No | Current |
| 0299-3822-06 | 00299382206 | 16 KIT in 1 BOX (0299-3822-06) > 1 BLISTER PACK in 1 KIT > 4 CAPSULE in 1 BLISTER PACK | 16 kit | 2010-05-14 | 0000-00-00 | No | No | Current |
| 0299-3822-07 | 00299382207 | 24 TRAY in 1 BOX (0299-3822-07) > 4 CARTON in 1 TRAY > 1 BLISTER PACK in 1 CARTON > 2 CAPSULE in 1 BLISTER PACK | 24 tray | 2015-02-01 | 0000-00-00 | No | No | Current |
| 0299-3822-30 | 00299382230 | 30 CAPSULE in 1 BOTTLE (0299-3822-30) | 30 capsule | 2010-05-14 | 0000-00-00 | No | No | Current |